What happens after a Form 483 is issued?

The firm typically has 15 business days to submit a written response describing planned corrections. FDA reviews that response, and unresolved or serious findings can lead to a Warning Letter, import alert, or other enforcement action, though many 483s are resolved without further FDA action.

Has GenoGenix, LLC had other FDA inspection citations?

This is the only FDA action Argus HQ has on file for GenoGenix, LLC so far. Argus ingests new FDA records daily.

What is the FEI / inspection ID for this Form 483?

FEI / inspection ID: 3032144832.

Is a Form 483 the same as a Warning Letter?

No. A Form 483 lists an FDA investigator’s observations at the close of an inspection; it is not a final agency determination. FDA may or may not follow up with a Warning Letter depending on the firm’s response and the severity of the findings.

Form 483 Record: GenoGenix, LLC, July 18, 2025

Here's the summary: FDA inspected GenoGenix, LLC in Florida and issued a Form 483 listing 16 inspectional observations following an inspection that concluded 2025-07-18. FDA records classify GenoGenix, LLC as a outsourcing facility. A Form 483 documents an investigator's findings at the close of an inspection under the Federal Food, Drug, and Cosmetic Act; it is not a final agency compliance determination. The observations on this page are drawn directly from the FDA-issued Form 483 record.

Key facts

Firm	GenoGenix, LLC
FEI / inspection ID	3032144832
Inspection end date	July 18, 2025
Citation count	16

What a Form 483 means

A Form FDA 483 is issued at the close of an FDA facility inspection to list conditions an investigator observed that may violate the Federal Food, Drug, and Cosmetic Act or its implementing regulations. It reflects the investigator's professional judgment at that point in time and is not a final agency determination, an enforcement action, or proof that a violation occurred. Firms are expected to respond in writing, typically within 15 business days, describing the corrective and preventive actions they plan to take. FDA reviews that response, along with any follow-up evidence, before deciding what happens next. Many 483s are resolved through corrective action alone. When FDA judges a firm's response inadequate, or when the underlying conditions are serious enough, the observations documented here can lead to a Warning Letter or further regulatory action. This page presents the observations exactly as recorded on the FDA-issued document; always confirm citation language against the original record before relying on it.

Citations explained

Observation 1 — Procedures designed to prevent microbiological contamination of drug products pmpo1iing to be

Procedures designed to prevent microbiological contamination of drug products pmpo1iing to be sterile did n ot include validation of the process. Specifically, A) On 07/ 16/2025, we observed three lots of sterile intact injectable diugs with visible contaminants and within expiiy which were all released and distributed: Vials examined Contaminants Observed L-Glutamine 25 mg/ mL 30 mL vial Lot# GG042225-025 Mf g. [(6) (4) IEXP. 10/21/2025 f('I vials • r:J vials with numerous particulates • At lea st five vials with numerous fibrous filaments and spherical clump s floating or adhering to the inner wall and lower stoppers. Alpha Lipoic Acid 25 mg/ mL 30 mL vial Lot# GG050525-004 Mfg. [(6) (4) IEXP. 11/01/2025 47 vials • 20 vials with one to three pa1ticulates Glutathione Preserved 200 m g/ mL 30 mL vial Lot # GO?l 125 002 GG071125-002 Mfg .[(D) -(4) IEXP. 10/ 10/2025 30 vials • 5 vials with numerous particulates Bei Y. DATE ISSUED SEE REVERSE Bei.

Observation 2 — The responsibilities and procedmes applicable to the quality control unit are n

The responsibilities and procedmes applicable to the quality control unit are n ot in writing and fully fo llowed. Specifically, your fnm has manufa ctured and released drug products without quality unit (QU) oversigh t. A. Your QU has not established control over: • The release specifications of finis hed drng products, including the review and approval for release and distribution. • Recall, reject, and quarantine of drng products and active phann aceutical ingredients (APis) held , m anufactured, labeled, and/or repackaged at this facility. • Drng products reprocessed and repackaged at this facility. • Changes to diug fo1mulations, components, and manufactur ing step s. Labels and info1mation listed on the di11g product labels. • Employee training and qualifications for cGMP manufacturing B. Your QU has not implemented sterility ass urance programs for injectable di11g products manufactmed at this facility, these includes: • Contamination control strategies -e. g., • Environmental monitoring is not established. • Cleaning validations is not established..

Observation 3 — There is a fa ilure to thoroughly review any unexplained discrepan cy

There is a fa ilure to thoroughly review any unexplained discrepan cy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been ah-eady distributed. Specifically, A)Your fom failed to initiate an investigation after a power outage on July 12, 2025, which inten11pted the power supplies to your cleamooms and refrigerators used for product storage. On [{6) (4) I, your fnm recolll1llenced sterile manufacturing without perfo1ming any sterility impact assessment and dete1mination on the length of the power outage. The following lots were manufactured o~{ b) {4 ) I: • Ascorbic Acid (Vitamin C) Preservative Free 500mg/mL 30mL Multi-Dose Vials Lot# GG071425-002, Mfg. [{6) (4) I, EXP. 10/ 13 /2025 • Bacteriostatic Water Sterile \Vaster fer ~jeette a USP, 0.9% Benzyl Alcohol 30 mL Multi- Dose Vials, Lot# GG07 1425-004, Mfg. [{b ) {4 I, EXP. 07/ 13 /2027 • Bacteriostatic Water Sterile ·waster fer Iajeettea U£P.

Observation 4 — Aseptic processing areas are deficient regarding the system for monitoring environmental conditions

Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. Specifically, A) Your fnm has not performed any environmental monitoring during aseptic operation since you started manufacturing and releasing sterile dm g products fr om August 2024 to July 2025. B) Your fnm has not perfo1med personnel monitoring during aseptic operations since you started manufacturing and releasing sterile drng products from August 2024 to July 2025. C) Your fnm does not perfo1m continuous pressure differential monitoring in your ISO 7 cleanrooms. You only per fo1m pressure differential at the [(b) (4 )_ j of your production day. Pressure differentials monitored P>) (4~production began around 06/12/202 5. D) Your fnm had a power outage sometimes during July 12 , 20 25 , however, your fnm has not dete1mined the length of the outage, nor taken appropriate steps to mitigate the issue, for example but not limited to perfonning any environmental monitoring following cleaning. E) Your fnm has no cleaning.

Observation 5 — Laborato1y controls do not include the establishment of scientifically sound and appropriate

Laborato1y controls do not include the establishment of scientifically sound and appropriate specifications, standai-ds, sampling plans and test procedures designed to assure that components, closures, in-process materials and drng products coufonn to appropriate standards of identity, strength, quality and purity. Specifically, Aj Your film failed to consistently conduct required testing 0 11 manufactured lots prior to May 2025. The absence of systematic lot testing compromises batch release procedures and prevents verification that each lot coufonns to established specifications before distribution. Lots without documented release testing include: • NAD 200mg/ml Lot# GG121624-023 • L-Glutamine 25 mg/ mL 30 mL vial Lot# GG042225-025, Mfg. [(6) (4) I, EXP. 10/21/2025 • MSC Exosomes Reconstitution Solution 20% MSC Exosomes. [b (4) ~ osomes per vial, 8mL in a l0mL Multi-Dose Vial L ot# GG052825-019, Mfg. (b) (4) I, EXP. 11/12/2025 • Alpha Lipoic Acid 25mg/mL 30mL vial Lot# GG050525-004, Mfg. [{ b ) {4 ) I, EXP. 11/01/2025

Observation 6 — Reprocessing procedures lack the steps to be taken to ensure that reprocessed

Reprocessing procedures lack the steps to be taken to ensure that reprocessed batches will coufo1m with all establis hed standards, specifications, and characteristic s. Specifically, Your film did not complete an investigation for released reprocessed material from a batch of that had been calculated to be super potent in the initially released portion. Your fo-m did n ot perfo1m product testing to verify the reprocessed material met specifications. Aft er recalling half of the batch due to Dig itally signed by DATE ISSUED Rei Y. He, lon·s tigator Bei y He - SEE REVERSE s • Bet Y. He -S Sarah Arf. Gauna, lnn-stigator Date: 2025.07.31 7/ 1 8/20 25 OF THIS PAGE 15:28:00-04'00' PAGE 11 ofl9 PAGES FORM FDA ~83 (09/08) PRl!VIOIJS EDIIlON OBSOLJm! INSPECTIONAL OBSERVATIONS

Observation 7 — Buildings used in the manufacture, processing, packing, or holding of a dm

Buildings used in the manufacture, processing, packing, or holding of a dm g product do not have the suitable construction to facilitate cleaning, maintenance, and proper operations. Specifi ca lly, A) Your "Ceiling Cassette" located in the ISO 7 cleanrooms circulate air without HEPA filtration. The absence of HEPA filtration on this un it compromises the cleanroom's ability to control airborne paiiiculate contamination and mainta in the designed cleanliness levels necessaiy fo r aseptic manufacturing operations. Additionally, your ISO 7 cleanrooms lacks air return capability while the adjacent ISO 8 room has a ceiling-mounted air return. B) The door frame between your ISO 7 cleanroom and ISO 7 "area" room appears to be constructed of wood-like material. Wood is porous and cannot be adequately clean ed and dis infected to ma intain the controll ed environn1ent standai·ds required fo r cleanroom operations. C) Your cleanroom sliding glass doors have visible gaps that could compromise the integrity of the controlled environment..

Observation 8 — Repo1is of analysis from component suppliers are accepted in lieu of testing

Repo1is of analysis from component suppliers are accepted in lieu of testing each component for confo1mity with all appropriate written specifications, without per fo1ming at least one specific identity ·, y He -Be Digitally signed by OATEISSUEO • Bef Y.He-S SEE REVERSE Bti Y. He, Inns~·ator Sarah A·f, Gauna, nstigator Date: 2025 .07.31 7/ 1 8/202 5 OF THIS PAGE s 15:37:27 -04'00' PAGE

Observation 9 — Batch production and control records are not prepared for each batch of

Batch production and control records are not prepared for each batch of drng product produced and do not include complete information relating to the production and control of each batch. Specifically, A) Your furn has not provided complete disu·ibution records. When requested during the inspection, you were unable to provide distr·ibution records containing the required elements including name, strength, dosage f01m, recipient name and address, date, quantity shipp ed, and lot number for drng products distr·ibuted from Janua1y 2024 to July 2025. This failure compromises your ability to conduct effective recalls and maintain proper u·aceability of disu-ibuted products. B) Your furn only started documenting and using draft batch records in May 2025, e.g. , you do not have batch records for the following: • L-Glutamine 25 mg/ mL 30 mL vial Lot# GG042225-025, Mfg. (o) (~) , EXP. 10/21/2025. Additionally, dun a visual examination of this lot on July 16, 2025, we obse1ved contaminants in all 4 J1>T< vials of.

Observation 10 — Strict control is not exercised over labeling issued for use in drng

Strict control is not exercised over labeling issued for use in drng product labeling operations. Specifically, A. On July 14, 2025, we observed five pre-printed and unsecured labels stored in the finished product refrigerator. The following info1mation is listed on the label "Rapamycin 2.5 mg Capsules" '(ll> f4> Capsules" b 4 "For Research Purposes Only" "Manufactured fo1 b 4 " "Made in the USA" "LOT: GG070225-001" "MFG: b 4 ""EXP: 07/01/2026" B. Your batch record for Glutathione Prese1ved 200mg/mL in 30mL vials Lot# GG071125-002, Mfg. b 4 ,EXP. 10/01/2025 has 4 (bH 1of b 4 listed as a component of the batch. The product is labeled as Glutathione Prese1ved 200mg/mL 30mL Multi-Dose Vial and does not include the (o) (~) listed on the batch record. This roduct was com ounded on (o) (~) •Y.Bel Digitally signed D 7 AT / E 1 ISSUED SEE REVERSE lkiY.He,Innstigator 1,y s.; v. He-S 8/20 25 Sarah M. GaUJIJI, Innsligator He -S OF THIS.

Observation 11 — Control procedures are not established which of those manufacturing processes that may

Control procedures are not established which of those manufacturing processes that may be responsible for causing variability in the charncteristics of in-process material and the drng product. Specifically, Your firm does not perfonn 100% visual inspection for particulate matter on sterile drng products packaged in amber vials, nor does your fnm perfo1m Acceptable Quality Level (AQL) testing. For example: • Batch Record Docmnent Number (b) (4) _J fo r Alpha Lipoic Acid 25 mg/mL, Lot Nmnber GG050525-004, manufactured on (b) (4) ("with expiration date 10/01/2025, o Step 5.2 states: "Perfo1m Visual Inspection on all finished product bottles/vials. For amber vials or opaque or translucent vials/containers, inspect for container integrity. For clear vials or containers, inspect for container integrity and product pa1ticulates. o Step 5.2.3 indicated that all vials passed 100% visual inspection; however, your actual practice does not include pa1ticulate inspection for amber vials. • Batch Record Docmnent Nmnber b) ( 4) Ifor Glutathione Preserved 200 mg/mL in 30 mL.

Observation 12 — Employees engaged in the manufacture, processing, packing and holding of a drug

Employees engaged in the manufacture, processing, packing and holding of a drug product lack the education, training and experience required to perfonn their assigned functions. Specifically, Your fnm failed to provide documentation of training or relevant experience for all your technicians involved in sterile processing operations.

Observation 13 — The labels of your outsourcing facility's drng products do not include info1mation

The labels of your outsourcing facility's drng products do not include info1mation required by section 503B(a)(10)(A) of the Federal Food, Drng, and Cosmetic Act (FD&C Act). Specifically, A. The labels for some of your outsourcing facility's drug products do not include info1mation required by section 503B(a)(10)(A). Specifically, the following info1mation is not found on your dmg product labels: • The established name of the diug; Examples of your diug product labels that do not contain this info1mation, include but are not limited to: Rapamycin 2.5mg caps, Clear Mind 150 (NAD+ 150mg/mL) Nasal Spray and LIPO (MIC) + B Multi.dose Vial • The dosage f01m; Examples of your diug product labels that do not contain this info1mation, include but are not limited to:, LIPO (MIC)+ B Multi.dose Vial and B-Complex Multi.dose Vial • A list of active and inactive ingredients, identified by established name and the quantity or prop011ion of each ingredient. Examples of your diug product labels that do not.

Observation 14 — The con tainer of your outsourcing facility's drng products does not include

The con tainer of your outsourcing facility's drng products does not include infonnati on required by section 503B(a)(10)(B) of the Federal Food, Drng, and Cosmetic Act (FD&C Act). Specifically, -A. The containers of your outsourcing facility' s drug products do not include inf01mation required by section 503B(a)(10)(B). Specifically, your containers do not include the following info1mation: • Infonnation to facilitate adverse event repo1ting: www.fda.gov/medwatch and 1-800- FDA- 1088; Examples of your container labels that do not contain this information: • hmnune Defense Nasal Spray • Directions for use, includin g, as appropriate, dosage and administration. Examples of your container labels that do not contain this info1mation: • Innnune Defense Nasal Spray EO H Y. OATEISSU Bei Y. e, Innsti::ator Bei He-~~~:t•1nec1by SEE REVERSE Sarah Af. Gauna, Innstigato1· 7 /18/2025 $ ~;:.:2~.~- 1 OF THIS PAGE PAGE 18 of19 PAGES

Observation 15 — Your outsourcing facility compounds diug products us ing bulk diug substances that

Your outsourcing facility compounds diug products us ing bulk diug substances that cannot be used in compounding under section 503B of the Federal Food, Drng, and Cosmetic Act (FD&C Act) because they (a) are not used to compound di·ug products that appear on the diug shortage list in effect under section 506E of the Act and (b) do not appear on a list developed by FDA of bulk di·ug substances for which there is a clinical need. Specifically, You produce and distribute diug products containing bulk diug substances that are ineligible for use in human diug compounding, including but not limited t oi{ 6) (4) [(6) (4)j.

Observation 16 — Your outsourcing facility has not submitted a report to FDA identifying a

Your outsourcing facility has not submitted a report to FDA identifying a product compounded during the previous six months as required by section 503B(b)(2)(A) of the Federal Food, Drng, and Cosmetic Act (FD&C Act). Specifically, Your outsourcing facility did not submit a report to FDA identifying all the di11gs compounded during the previous six-month period. Specifically, you did not submit the required initial product repo1t or the required biannual product report for June 2025. *DATES OF INSPECTION 07/14/2025 (Mon), 07/15/2025 ( Tu e), 07/16/2025 (Wed), 07/17/2025 (Thu), 07/18/2025 (Fri), SEE REVERSE OF TH IS PAGE lki Y. Bet Inns~·o-ator Sarah } ,f , Gauna, ,·estigato1· Sarah M. ~~=~ Gauna-s=~~• Bei Y. Digit.illy signed bylleiY. He -S He-S Date: 2025.07.31 15:44:26 --04'00' OATEISSUEO 7 /18/2025

GenoGenix, LLC’s FDA history

Argus HQ has recorded 1 total FDA action tied to GenoGenix, LLC: 0 warning letters, 0 recalls, 0 approval records, and 1 Form 483 inspection citation.

Frequently asked questions

What happens after a Form 483 is issued?: The firm typically has 15 business days to submit a written response describing planned corrections. FDA reviews that response, and unresolved or serious findings can lead to a Warning Letter, import alert, or other enforcement action, though many 483s are resolved without further FDA action.
Has GenoGenix, LLC had other FDA inspection citations?: This is the only FDA action Argus HQ has on file for GenoGenix, LLC so far. Argus ingests new FDA records daily.
What is the FEI / inspection ID for this Form 483?: FEI / inspection ID: 3032144832.
Is a Form 483 the same as a Warning Letter?: No. A Form 483 lists an FDA investigator’s observations at the close of an inspection; it is not a final agency determination. FDA may or may not follow up with a Warning Letter depending on the firm’s response and the severity of the findings.

See if this 483 escalates to a warning letter — before your auditor asks.

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Full FDA history for GenoGenix, LLC

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2025). Form 483 Record: GenoGenix, LLC, July 18, 2025 — 16 Citations. Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-genogenix-llc-2025-07-18-3032144832

MLA

"Form 483 Record: GenoGenix, LLC, July 18, 2025 — 16 Citations." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-genogenix-llc-2025-07-18-3032144832.

Chicago

Argus HQ Research. "Form 483 Record: GenoGenix, LLC, July 18, 2025 — 16 Citations." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/483/fda-483-genogenix-llc-2025-07-18-3032144832.

BibTeX

@misc{argushq_argushq_ai_483_fda_483_genogenix_llc_2025_07_18_3032144832_2025,
  title = {Form 483 Record: GenoGenix, LLC, July 18, 2025 — 16 Citations},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/483/fda-483-genogenix-llc-2025-07-18-3032144832},
  note = {Accessed: July 13, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗