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.

Does this Form 483 mean PQ Pharmacy 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.

FDA Inspects PQ Pharmacy LLC: Form 483 with 4 Citations (April 4, 2025)

FDA inspected PQ Pharmacy LLC in Florida and issued a Form 483 listing 4 inspectional observations following an inspection that concluded 2025-04-04. FDA records classify PQ Pharmacy 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	PQ Pharmacy LLC
FEI / inspection ID	3017374013
Inspection end date	April 4, 2025
Citation count	4

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 — Your fnm fail ed to establish adequate written procedures for production and

Your fnm fail ed to establish adequate written procedures for production and process controls designed to assure that the diug products have the identity, strength, purity, and quality that th ey are purported or re presented to possess. Specifically, 11 a)Your fnm failed to conduct hold time studies to justify the fi "jday hold times for your bulk solution bag before dosing into fi nal product containers for al products. While a media fi ll was per fo1med to challenge the F1T4 j daY hold period, your fnm has not assessed potential risks or the impact of extended hold times on the fi nished product and its sh elf li fe. Batches that unde1went hold times during processing were not includ ed in stability studies. Additionally, no studies have been conducted to define the storage conditions, nor do they addi·ess the container closure system (packaging integrity), chemical stability, or sampling timepoints. For example, the following lots unde1went hold times during.

Observation 2 — Procedures designed to prevent microbiological contamination of diug products pmp o1ting to

Procedures designed to prevent microbiological contamination of diug products pmp o1ting to be sterile are not fo llowed. EM PLOYE E($) SIGNATURE DATE lSSUEO SEE REVERSE J o se R Lopez, Compliance Officer Jose R. ..,,.,• ._ 4/4/2025 OF Lopez =:,.~ THIS PAGE Martinez~ X 1-s :~oo FORM PAGE 4 of8 FDA 483 (09/08) TIO AGES PREVIOUS EDmON OBSOlEJE INS PE C NAL OBSERVATIONS P

Observation 3 — Aseptic processing areas are de fi cient regarding the system fo r

Aseptic processing areas are de fi cient regarding the system fo r monitoring environmental conditions. Specifically, a ) 4 Your videos of smoke studies conducted on 09/23/2024 fo r PEC ID lbl < do not demonsti·a te the manipulations or conditions necessaiy to accurately represent the dynamic process used in the production of Semaglutide, Tirzepatide, Moxifl o:i;cac in HCL, and Phen7 hrine/Lidocaine. For exampl e, Smoke Study 23SEP2024, PEC ID 61141 SIN [(Q[ @: ) , 5mL Vial Crimping Dynamic, does not include the steps fo r aseptically capping and crimping vials during the dosing process. b) Smoke Studies conducted in September 2024 app eai· to exhibit turbulence in the Non-hazai·dous Cleanroom 1 ISO- 7 area, the Lamin ai· Flow Hood PEC ID 4 1>ll l , and PEC ID 4 !6)T . For example, Non-Hazardous Sui te Smoke Study, September 2024, CleanroorrCj shows u pward air fl ow between the 15:00 and 16 .J :00 minute m ai·ks ..

Observation 4 — Written recor ds of investi ga tions into unexplained discrepancies do not

Written recor ds of investi ga tions into unexplained discrepancies do not always inclu de the conclusions and follow-up. Speci fi ca lly, a )Deviation repo1i DEV2024072, initiated on 09/18/2024, was opened to investigate the presence of visible paiiiculate identified during the bulk bag inspection. The defect was detectedKo) (4) l, prior to dosing stage of the steri li zed 7.2L bulk solution con ta ining Prednisolone Sodium Phosphate/Moxifl oxacin HCVBrom fe nac I %/0.5%/0.09% Ophthahnic Solution, Lot: [(6) (4) 1. As a con ective action your fnm [ 6) (4) j the bulk solution bag and subsequently released the batch for distribution. However, the investigation was inadequate as it did not establish a definitive root cause fo r the presence of visible oaiiiculates fo ll owing [(6) (.::I:)]. Additiona lly, the investigation fa iled to assess potential b 4) ._J concerns or identi fy the source of paiiiculate containination, thereby limiting tlie implementation of e ffective conective and preventive.

PQ Pharmacy LLC’s FDA history

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

Frequently asked questions

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.
Does this Form 483 mean PQ Pharmacy 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.

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Full FDA history for PQ Pharmacy 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). FDA Inspects PQ Pharmacy LLC: Form 483 with 4 Citations (April 4, 2025). Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-pq-pharmacy-llc-2025-04-04-3017374013

MLA

"FDA Inspects PQ Pharmacy LLC: Form 483 with 4 Citations (April 4, 2025)." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-pq-pharmacy-llc-2025-04-04-3017374013.

Chicago

Argus HQ Research. "FDA Inspects PQ Pharmacy LLC: Form 483 with 4 Citations (April 4, 2025)." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/483/fda-483-pq-pharmacy-llc-2025-04-04-3017374013.

BibTeX

@misc{argushq_argushq_ai_483_fda_483_pq_pharmacy_llc_2025_04_04_3017374013_2025,
  title = {FDA Inspects PQ Pharmacy LLC: Form 483 with 4 Citations (April 4, 2025)},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/483/fda-483-pq-pharmacy-llc-2025-04-04-3017374013},
  note = {Accessed: July 13, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗