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

FEI / inspection ID: 3022250654.

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.

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.

ProRx LLC — FDA Form 483 Inspection, September 19, 2025 (3 Citations)

Key facts

Firm	ProRx LLC
FEI / inspection ID	3022250654
Inspection end date	September 19, 2025
Citation count	3

Key takeaway: FDA inspected ProRx LLC in Pennsylvania and issued a Form 483 listing 3 inspectional observations following an inspection that concluded 2025-09-19. FDA records classify ProRx 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.

Citations explained

Observation 1 — There is a failure to thoroughly review any unexplained discrepancy and the

There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or n ot the batch has been ah-eady distributed. Specifically, A. Your fum failed to investigate media fill vials with positive microbial growth. Operators (11)('~<• and 1>>{6);(11> conducte (b} (4) media fill batches on consecutive days (March24 -26, 2025), with each operator required to fill (6) {4> trays of vials per batch for qualifying operators for aseptic production. On April 8, 2025, positive microbial growth was repo1ted for one vial from the first batch of each operator from the March 24, 2025 media fill batch. No positive growth was reported in the March 25 or the March 26, 2025 media fill batches. Your furn did not investigate the root cause of the positive growth events and d id not perfo1m microbial identification of the affected vials. Despite these contamination events, both operators.

Observation 2 — Procedures designed to prevent microbiological contamination of drng products purporting to be

Procedures designed to prevent microbiological contamination of drng products purporting to be sterile are not established, written and followed. Specifically, A. Aseptic techniques were not adequately demonstrated during aseptic processing operations. On September 9, 2025, during the production of Tirzepatide Injection 45 mg/2.5 rn.L , Lot# 41 Pro1x09092025(6H ; Tirzepatide Injection 45 mg/2.5 mL, Lot# Pro1x0909202f l<4i; and Glutathione 2,000 mg/10 mL, Lot# Pro1x09202 5!6H 4 I, the following deficiencies were obse1ved: • The operator working in the ISO Class 5 area disrnpted unidirectional airflow by extending their foreanns over the container to retrieve each stopper and place it onto a vial during the stoppering process inside the ISO Class 5 hood EMPLOY EE(S) SIGNATURE DATE ISSUED SEE REVERSE Taichun Qin, Investigat or 9/ 1 9/2025 OF THIS PAGE T.idlll'IQl tr.n, 09:AS: ~ 200132.4646 : 09-1..2025 X ~

Observation 3 — Procedures designed to prevent microbiological contamination of drng products purporting to be

Procedures designed to prevent microbiological contamination of drng products purporting to be sterile did n ot include adequate validation of the aseptic and sterilization process. EMPLOY EE(S) SIGNATURE DATE ISSUED SEE REVERSE Taichun Qin, Investigat or 9/ 1 9/2025 OF THIS PAGE ~tr. T.idlll'IQln, 2:00132A646 ~SIQned: 09-1..2025 X 09:A&'2l

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.

ProRx LLC’s FDA history

Argus HQ has recorded 2 total FDA actions tied to ProRx LLC: 1 warning letter, 0 recalls, 0 approval records, and 1 Form 483 inspection citation.

Frequently asked questions

What is the FEI / inspection ID for this Form 483?: FEI / inspection ID: 3022250654.
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.
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.

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

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Full FDA history for ProRx LLC

Warning letter: ProRx LLC — Compounding Pharmacy/Adulterated Drug Products (2026-04-07) →

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). ProRx LLC — FDA Form 483 Inspection, September 19, 2025 (3 Citations). Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-prorx-llc-2025-09-19-3022250654

MLA

"ProRx LLC — FDA Form 483 Inspection, September 19, 2025 (3 Citations)." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-prorx-llc-2025-09-19-3022250654.

Chicago

Argus HQ Research. "ProRx LLC — FDA Form 483 Inspection, September 19, 2025 (3 Citations)." Digital Empire LLC. Accessed July 15, 2026. https://argushq.ai/483/fda-483-prorx-llc-2025-09-19-3022250654.

BibTeX

@misc{argushq_argushq_ai_483_fda_483_prorx_llc_2025_09_19_3022250654_2025,
  title = {ProRx LLC — FDA Form 483 Inspection, September 19, 2025 (3 Citations)},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/483/fda-483-prorx-llc-2025-09-19-3022250654},
  note = {Accessed: July 15, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗