Key facts
| Firm | Park Avenue Compounding |
|---|---|
| FEI / inspection ID | 1972829 |
| Inspection end date | September 23, 2025 |
| Citation count | 7 |
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 purporting to be
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process. Specifically, A. Media fills completed by compounding operators are not representative of your firm ' s largest batch size. 1. Your firm 's media fill "Proces is designed with a batch size o units, while your firm 's largest batch size produced and distributed from this facility is units. Your firm has not provided sufficient scientific justification for the discrepancy in units produced in the media fill "Proces 2. Your firm ' s media fill "Proces is designed with a batch size o firm's largest batch size produced and distributed from this facility is firm has not provided sufficient scientific justification for the discrepancy in units produced in the media fill "Proces B. Your firm ' s Media Fill records document the destruction of media fill units without adequate scientific justification. For example, but not limited to: With.
Observation 2 — Aseptic processing areas are deficient regarding the system for cleaning and disinfecting
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions. Specifically, on 9/19/2025, during your firm's "Terminal Cleaning" of the ISO-7 classified buffer rooms, completed by your firm' s contracted vendor, we observed the following deficiencies: A. Cleaning technician used their gloved hands to adjust their sterile boot, exposing their skin to ISO 7 Buffer Roo (Room 151 ). B. Cleaning technician in Buffer Roo (Room 151) was observed kneeling on the ISO 7 floor with their knees to clean the wheels of a ___ _. cart, then continue cleaning without changing their sterile coverall and sterile boots. C. Cleaning technician in Buffer Roo (Room 149) was observed sitting on the ISO 7 floor to clean the bottom of the ISO 5 LAFH, then continue cleaning without changing their sterile coverall and sterile boots.
Observation 3 — Aseptic processing areas are deficient regarding air supply that is filtered through
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure. Specifically, your firm' s June 2025 airflow evaluation (smoke studies) of the 1SO-5 c1assified area where aseptic operations are performed shows unidirectional airflow is compromised and eddies/turbulence was observed under dynamic conditions. For example, but not limited to: A. Tirnestamp: at approximately 1. During critical manipulations in your aseptic operations, your aseptic operator was observed leaning against the workbench, which resulted in AMENDMENTl EMPI_ OYEE(S) SIGNATURE DATE ISSUED SEE REVERSE June P Page, Ma n u f acturing Compounding 9/ 2 3/2025 OF THIS PAGE Quality Expert Sa r ah M Gauna , Manufacturing Compounding Quality Expert FORM FDA -18.l of14PAGES (09108) PREVIOUS EDffiON INSPECTIONAL OBSERVATIO S PAGE 3 OBSOLETE
Observation 4 — AMENDMENTl EMPI_ OYEE(S) SIGNATURE DATE ISSUED SEE REVERSE June P Page, Ma
AMENDMENTl EMPI_ OYEE(S) SIGNATURE DATE ISSUED SEE REVERSE June P Page, Ma n u f actur in g Compou n d in g 9/ 2 3/2025 OF THIS PAGE Quality Expert Sa ra h M Gauna , Ma nu f ac tu ring Compo un ding Quality Expert FORM FDA -18.l (09108) PREVIOUS EDffiON OBSOLETE INSPECTIONAL OBSERVATIO S PAGE4of14PAGES
Observation 5 — Acceptance criteria for the sampling and testing conducted by the quality control
Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate to assure that batches of drug products meet each appropriate specification and appropriate statistical quality control criteria as a condition for their approval and release. Specifically, A. Your firm lacks scientific justification for visual inspection re-inspection procedures: AMENDMENTl EMPI_ OYEE(S) SIGNATURE DATE ISSUED SEE REVERSE June P Page, Ma n u f actur in g Compou n d in g 9/ 2 3/2025 OF THIS PAGE Quality Expert Sa ra h M Gauna , Ma nu f ac tu ring Compo un ding Quality Expert FORM FDA -18.l (09108) PREVIOUS EDffiON OBSOLETE INSPECTIONAL OBSERVATIO S PAGE 7 of 14PAGES
Observation 6 — Drug product production and control records, are not reviewed by the quality
Drug product production and control records, are not reviewed by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed. Specifically, a review of your firm's batch records found your firm released purportedly sterile drug products before reviewing the completed deviations or complaints associated with each batch. For example, but not limited to: AMENDMENTl EMPI_ OYEE(S) SIGNATURE DATE ISSUED SEE REVERSE June P Page, Ma n u f actur in g Compou n d in g 9/ 2 3/2025 OF THIS PAGE Quality Expert Sa ra h M Gauna , Ma nu f ac tu ring Compo un ding Quality Expert AGES FORM FDA -18.l (09108) PREVIOUS EDffiON
Observation 7 — Appropriate controls are not exercised over computers or related systems to assure
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel. Specifically, A. Your firm utilizes a shared network that is accessible to all employees (operations, production, and quality) to access your firm' s Quality Control Documents. For example, but not limited to: 1. Environmental and Personnel Monitoring, Deviations, Complaints, Change Controls, Validation Protocols. Your non-quality personnel has unrestricted to access make changes to the following: 1. Uncontrolled excel spreadsheet used to track and trend your firm's environmental monitoring for classified areas. 11. Modify, delete, add data to complaint files. B. Your computerized software used for batch record release includes quality events associated with each batch record release (complaints, deviations, recalls, non-conformances). However, your firm does not have any written procedures for electronic reviews and has not performed any electronic audit trails to track the creation, modification, or deletion of such data.
Park Avenue Compounding’s FDA history
Argus HQ has recorded 1 total FDA action tied to Park Avenue Compounding: 0 warning letters, 0 recalls, 0 approval records, and 1 Form 483 inspection citation.
Frequently asked questions
- Has Park Avenue Compounding had other FDA inspection citations?
- This is the only FDA action Argus HQ has on file for Park Avenue Compounding so far. Argus ingests new FDA records daily.
- What is the FEI / inspection ID for this Form 483?
- FEI / inspection ID: 1972829.
- 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 Park Avenue CompoundingCompiled 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). Form 483 Record: Park Avenue Compounding, September 23, 2025 — 7 Citations. Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-park-avenue-compounding-2025-09-23-1972829
"Form 483 Record: Park Avenue Compounding, September 23, 2025 — 7 Citations." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-park-avenue-compounding-2025-09-23-1972829.
Argus HQ Research. "Form 483 Record: Park Avenue Compounding, September 23, 2025 — 7 Citations." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/483/fda-483-park-avenue-compounding-2025-09-23-1972829.
@misc{argushq_argushq_ai_483_fda_483_park_avenue_compounding_2025_09_23_1972829_2025,
title = {Form 483 Record: Park Avenue Compounding, September 23, 2025 — 7 Citations},
author = {{Argus HQ Research}},
year = {2025},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/483/fda-483-park-avenue-compounding-2025-09-23-1972829},
note = {Accessed: July 13, 2026}
}