Park Avenue Compounding
Form 483 issued September 23, 2025 · Saint Louis, Missouri
- Inspection
- Sep 11 – Sep 23, 2025
- Investigators
- June P. Page· Sarah M. Gauna
- Observations
- 8
- Pages
- 15
- FEI number
- 1972829
In short: On September 23, 2025, FDA issued a Form 483 with 8 observations to Park Avenue Compounding in Saint Louis, Missouri (FEI 1972829) after an inspection that ran Sep 11 – Sep 23, 2025. The investigators were June P. Page and Sarah M. Gauna. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and quality system account for 6 of 8 observations.
Most cited: 21 CFR 211.42 (2×) · 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 02
Aseptic processing areas are deficient regarding the system for■ cleaning and disinfecting the room and equipment…
- 03
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air…
- 04
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
June P. Page
30 documents · 2015–2025
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in India.
The firmPark Avenue Compounding history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Park Avenue Compounding?
FDA listed 8 observations on this Form 483, mostly about facilities & equipment, quality system and production. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Park Avenue Compounding?
June P. Page and Sarah M. Gauna are named on this Form 483, for the inspection of Sep 11 – Sep 23, 2025. Each investigator has a profile showing what they cite most.
When was Park Avenue Compounding inspected by FDA?
The inspection ran Sep 11 – Sep 23, 2025, and the Form 483 is dated September 23, 2025.
How do I get the full Form 483 for Park Avenue Compounding?
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