What is an FDA Form 483?

A Form FDA 483 lists an FDA investigator's written observations at the close of a facility inspection, issued under section 704(b) of the Federal Food, Drug, and Cosmetic Act. It documents conditions the investigator judged may violate FDA regulations. A 483 is not an enforcement action or a final determination that a violation occurred.

Does this Form 483 mean Revive Rx LLC violated the law?

No. A Form 483 documents an investigator's observations only. FDA reviews the firm's written response and any corrective actions taken before deciding whether further action is warranted, and many 483s are closed without additional enforcement once a firm shows adequate correction.

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 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.

Form 483 Record: Revive Rx LLC, March 27, 2026

Key facts

Firm	Revive Rx LLC
FEI / inspection ID	3016710945
Inspection end date	March 27, 2026
Citation count	5

The short version: FDA inspected Revive Rx LLC in Texas and issued a Form 483 listing 5 inspectional observations following an inspection that concluded 2026-03-27. FDA records classify Revive Rx LLC as a producer of sterile and non sterile drug products. 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.

Citations explained

Observation 1 — 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 environmental monitoring data shows persistent and repeated recovery of microorganisms, including mold and spore-forming bacteria, in both ISO Class 5 and ISO 7 classified areas. Recoveries in ISO 5 areas: 4 • 3/5/2025: 1 CFU Gram-positive rods (not identified) recovered post-batch in Hood <1>>< > • 4/3/2025: 1 CFU Gram-positive rods (not identified) recovered post-batch in Hood • 4/8/2025: 1 CFU Gram-positive rods (not identified) recovered post-batch in Hood • 4/8/2025 : 1 CFU Gram-positive rods (not identified) recovered post-batch in Hood 4 • 4/29/2025: 1 CFU (not stained, not identified) recovered post-batch in Hood(b>< > - • 5/12/2025: 1 CFU (not stained, not identified) recovered post-batch in Hood ,; (i11012025: 1 CFU Gram-positive rods identified as Streptomyces olivaceous recovered in Hood u D '~ • 8/5/2025 : 1 CFU identified as fungus Penicillium oxalicum recovered post-batch in Hood • 8/15/2025: 1.

Observation 2 — Lack of adequate personnel sampling

Lack of adequate personnel sampling. Specifically, Personnel monitoring fo r your operators is performed during the{6) (4) __J gowning qualification. After that personnel monitoring is performed during the [(I:)) (4 _=:I gowning competency assessment and 6) (4) I media fill qualifications. No routine personnel monitoring is performed upon completion of production batches. Colonies belonging to human flora were isolated from ISO 5 Hoods during production: • Hood □ S treptomyces olivaceous, during production ofTirzepatide Lot# 12246565 on 7/ 10/2025 • Hood Micrococcus luteus during production of Tirzepatide Lot #s 14031295 and 14162530 on 12/8/ 25..b}( and 4) 12/ 18/25. • Hood Micrococcus luteus during media fill on 3/24/2025 • Hood Micrococcus luteus during production of Semaglutide Lot# 14427530 on 1/ 12/26 • Hood Corynebacterium ureiceler during production ofNAD + Lot# 12231180 on 7/9/2025. - All the recovered isolates were not identified. However, after Gram staining, the firm categorized rest of the unidentified colonies to be of human origin.

Observation 3 — Smoke studies were not performed under dynamic condition s

Smoke studies were not performed under dynamic condition s. Specifically, lti) {4) lti) (4) Your firm conducted smoke studies on 2/9/2026 only under static conditions in Hoods and located in positive pressure clean room. These two ISO Class 5 primary engineering controls are used to compound injectable sterile drug products. The review of smoke studies performed in these hoods, in static conditions, showed empty hoods with single stream of smoke introduced towards the HEP A filter face. Your smoke studies under static conditions only do not provide an assurance that the first a ir from HEPA filters is maintained over critical sites (e.g.[(lj) (4~ bag filled with compounded drug,[(lj) (4) tubing, vials, vial stoppers) when operators position their hands and arms in the hood or when equipment and materials are arranged as during actual production, thereby creating conditions whereby sterile drug products may become contaminated. Since 09/26/2025 your firm has compounded approximately 0 4 < >< Ybatches of sterile drug.

Observation 4 — Sterile drugs and Materials were exposed to lower than ISO 5 quality

Sterile drugs and Materials were exposed to lower than ISO 5 quality air. Specifically, Your firm transfers 6 4 vials filled with drug products intended to be sterile from ISO Class 5 Biological Safety Cabinets (BSCs) through the ISO Class 7 negative pre ss ure cleanroom to 6 4 During this transfer, the 6 4 vials, which contain exposed sterile product, are subjected to air quality worse than ISO Class 5. Your firm also operates (15) (4) and (15) (4) located in the positive pressure cleanroom. (15) (4) vials are similarly transferred from ISO Class 5 hoods through the ISO Class 7 positive pressure cleanroom to these (15) (4) , exposing sterile products to worse than ISO Class 5 air quality during this transfer. On 03 /09/2026, I observed tl>H4Yvials ofHCG 12,000 IU Vial Lot # 15120575 Hood 1 ltiH" to 15 4 The vials were carried in approximately <0><4ltrays, 6 4 at a time, (b) (4) trays containing approximately.

Observation 5 — Use of!

Use of! 6) (4) I that are not sterilized by routine sterilization cycles and protected from contamination by sterilizing [6 Jl4] on vacuum break air lines/v ents. Specifically, On 3/ 10/26, your Production Manager stated that all of the [ 6) (4) I are cle aned after each production run using[(l5 ) (4) ~ .with a contact time o.~~fi (6) (4p , followed by :(6) (4) 1. 1(6) (4) sterilization is conducted b) (4) . Your firm does not use (o) (4 ) sterilization,[(6 ) (4) sterilization, or any other validated sterilization method to sterilize the interior chambers of the [(15 ) (4) I between production runs or on a routine basis. Tms IS A REPEAT OBSERVATION. *DATES OF INSPECTION 3/09/2026(Mon), 3/ 10/2026(Tue), 3/l l/2026(Wed), 3/l 2/2026(Thu), 3/ 13 /2026(Fri), 3/ 16/2026(Mon), 3/ 17/2026(Tue), 3/18/2026(Wed), 3/19/2026(Thu), 3/20/2026(Fri), 3/23/2026(Mon), 3/24/2026(Tue), 3/25/2026(Wed), 3/26/2026(Thu), 3/27/2026(Fri) SEE REVERSE OF THIS PAGE

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.

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

What is an FDA Form 483?: A Form FDA 483 lists an FDA investigator's written observations at the close of a facility inspection, issued under section 704(b) of the Federal Food, Drug, and Cosmetic Act. It documents conditions the investigator judged may violate FDA regulations. A 483 is not an enforcement action or a final determination that a violation occurred.
Does this Form 483 mean Revive Rx LLC violated the law?: No. A Form 483 documents an investigator's observations only. FDA reviews the firm's written response and any corrective actions taken before deciding whether further action is warranted, and many 483s are closed without additional enforcement once a firm shows adequate correction.
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 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.

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Full FDA history for Revive Rx 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 (2026). Form 483 Record: Revive Rx LLC, March 27, 2026 — 5 Citations. Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-revive-rx-llc-2026-03-27-3016710945

MLA

"Form 483 Record: Revive Rx LLC, March 27, 2026 — 5 Citations." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/483/fda-483-revive-rx-llc-2026-03-27-3016710945.

Chicago

Argus HQ Research. "Form 483 Record: Revive Rx LLC, March 27, 2026 — 5 Citations." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/483/fda-483-revive-rx-llc-2026-03-27-3016710945.

BibTeX

@misc{argushq_argushq_ai_483_fda_483_revive_rx_llc_2026_03_27_3016710945_2026,
  title = {Form 483 Record: Revive Rx LLC, March 27, 2026 — 5 Citations},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/483/fda-483-revive-rx-llc-2026-03-27-3016710945},
  note = {Accessed: July 13, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗