Key facts
| Firm | Revive Rx LLC |
|---|---|
| FEI / inspection ID | 3016710945 |
| Inspection end date | February 7, 2025 |
| Citation count | 6 |
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 — Sterile chugs and Materials were exposed to lower than ISO 5 quality
Sterile chugs and Materials were exposed to lower than ISO 5 quality air. Specifically, A.Your fom 's:~uproduct, Trimix Gel (300 mcg / 100 mcg / 1000 mcg per ml), is prepared with nonsterile (6) (4] that is[( b) (4) Ito be sterilized uncapped[( b (4) I staged in an unclassifi ed area. After the sterilization cycle, the opened and uncapp ed syringe is then capp ed using a 'sterile' cap before it is transfened into ISO 8/7 areas and ultimately, into a ISO 5 BSC for further processing. On 12/ 05 /2024, your fnm prepared □ syringes units ofTrimix Gel (300 mcg/ 100 mcg/ 1000 mcg per ml) for Intraurethral Inse1tion, Lot 10099621 BUD:03 /05/2025, with an uncapped[( b ) (4) Ithat was processed using[(b ) (4) ~·nan unclass ified area. There is no assurance that the unclassified area where the non-sterile l( b ) (~ ) is sterilized and use of a 'sterile cap' are not render ed unsterile.
Observation 2 — Microbial contamination was present in the ISO 5 area and areas adjacent
Microbial contamination was present in the ISO 5 area and areas adjacent to production areas. Specifically, A. Your fnm fails to add additional routine enviro nmenta l monitoring to the ISO 5 and ISO 7 critical areas to ensure that the processing conditions are free of mol d, yeast, and other spore fo1ming microorganisms fo und in your ISO 7 cleanroom areas and during routine personnel gowning qualifications. i. On 01/24/2024, a recove1y of Too Numerous To Count (TNTC) CFU of a gram p os itive, spore fo nning bacteria, Paenibacillus glucanolyticus, was recovered in the ISO 7 prep cleanroom used to prepare and mix solutions; ii. On 11 / 23 /2023, a 3CFU recove1y of mold, Penicillium sumatrense, was recovered in the ISO 7 preparation [(6) (~] hood used to prepare and mix solutions; iii. On 08/01/20 23 , there were three separate recoveries inside the ISO 7 negative pressure clean room used in the processing of dmg products.
Observation 3 — La ck of and Inadequate routine environmental monitoring in the ISO 5
La ck of and Inadequate routine environmental monitoring in the ISO 5 area and classified areas. Specifically, your fnm does not perfo1m an environmental monitoring surface sample when per fo1ming aseptic processing directly in within 6 inches of the work area that the process is being per fo1med. On 01/27/2025, the fnm 's quality technician was observed to take a sample of the work bench EMPLOYEE(S) SI GNATURE DATE ISSUED SEE REVERSE Jazmine N Brown, Inves t iga t or 2/7/2025 OF THIS PAGE F ORM FDA ~83 (09/ 08) PAGE 3 of6 PAGES PREVIOUS EDmON OBSOLEJE INS PEC TIONAL OB SERVATIONS
Observation 4 — Failure to conduct m edia fills that closely simulate aseptic production operations
Failure to conduct m edia fills that closely simulate aseptic production operations un de r the worst-case, most-challeng ing, and stressful conditions. Specifically, your fum 's media fill program is deficient in that your media fills are not representative of the batch size, container type, and equipment used fo r all di11g products produced intending to be sterile. A. Your fnm does n ot have a media fill fo r syringe diug products produced. For example, your fnm prepar esg 14 syringes ae <~ ; syringe for Trimix Gel (3 00 mcg / 100 mcg I l 000 mcg per ml) fo r Intrauret ·a Inse1tion wit out h aving conducted the appropriate media fill to demonstrate and assess aseptic processing when filling a syringe product inside of the ISO 5 enviro nment. B. Your fnm does n ot include interventions such as loading and unloading th J.(6) (,4) Iin your m edia fill program. The fo llowing products are[(6).
Observation 5 — Smoke studies were not per fo 1med under dynamic conditions
Smoke studies were not per fo 1med under dynamic conditions. Specifically, your smoke studies conducted August 22, 2024, during the cle amoom rece1i ification, are inadequate. For example, your fnm 's smoke studies do not consist of dynamic behaviors per fo1med to assess complex interventions within the ISO 5 biosafety cab inet hoods clas~(b) <4i. This is a repeat OBSERVATION.
Observation 6 — Failure to appropriately and regularly clean and disinfect or sterilize equipment located
Failure to appropriately and regularly clean and disinfect or sterilize equipment located in the ISO 5 area. Specifically, your fnm has n ot established a process for 4 b) < cleaning of the metal diffuser covering the 4 th 4 HEPA filters within the I>) ( biosafety cabinet (BSC) claa™s ><~~ l used ~oroduce drnr p;·o ducts purpo1ied to be sterile. Your fnm produces approximately (6) (4 lots ( I:>) (4)across the 4 :iJ < J BSCs located in your clean room suites. For example, on 01/27/2025, your operator made two d ifferent drng EMPLOYEE(S) SI GNATURE DATE ISSUED SEE REVERSE Jazmine N Brown, I nves t iga t or OF THIS PAGE -· ..8triecf9/:Jo\ZMIMEN - - 2/7/2025 . ~ X 0.817aei:t02-01-202S w..s:: F ORM FDA ~83 (09/ 08) TIO PAGE 5of6 AGES PREVIOUS EDmON OBSOLEJE INS PEC NAL OB SERVATIONS P
Revive Rx LLC’s FDA history
Argus HQ has recorded 2 total FDA actions tied to Revive Rx LLC: 0 warning letters, 0 recalls, 0 approval records, and 2 Form 483 inspection citations.
Frequently asked questions
- Has Revive Rx LLC had other FDA inspection citations?
- Yes. Argus HQ has recorded 2 total FDA actions tied to Revive Rx LLC, including 2 Form 483 inspection citations.
- What is the FEI / inspection ID for this Form 483?
- FEI / inspection ID: 3016710945.
- 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.
- Where can I read the full Form 483?
- The verbatim inspection record is the source of truth — always confirm citation language against the original FDA document before acting.
See if this 483 escalates to a warning letter — before your auditor asks.
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Related enforcement actions
Full FDA history for Revive Rx LLCCompiled 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.
Argus HQ Research (2025). Revive Rx LLC — FDA Form 483 Inspection, February 7, 2025 (6 Citations). Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-revive-rx-llc-2025-02-07-3016710945
"Revive Rx LLC — FDA Form 483 Inspection, February 7, 2025 (6 Citations)." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-revive-rx-llc-2025-02-07-3016710945.
Argus HQ Research. "Revive Rx LLC — FDA Form 483 Inspection, February 7, 2025 (6 Citations)." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/483/fda-483-revive-rx-llc-2025-02-07-3016710945.
@misc{argushq_argushq_ai_483_fda_483_revive_rx_llc_2025_02_07_3016710945_2025,
title = {Revive Rx LLC — FDA Form 483 Inspection, February 7, 2025 (6 Citations)},
author = {{Argus HQ Research}},
year = {2025},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/483/fda-483-revive-rx-llc-2025-02-07-3016710945},
note = {Accessed: July 13, 2026}
}