Overview
- 7 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-09-23.
At a glance
Inspections
7
Form 483s
6
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 11 Sep 2025 – 23 Sep 2025 | Human Drugs | 483 | View 483 → |
| 29 Jan 2024 – 8 Feb 2024 | Human Drugs | 483 | On file |
| 16 Sep 2021 – 28 Sep 2021 | Human Drugs | 483 | View 483 → |
| 20 Aug 2019 – 28 Aug 2019 | Human Drugs | 483 | View 483 → |
| 23 Oct 2017 – 16 Nov 2017 | Human Drugs | 483 | On file |
| 4 Aug 2014 – 14 Aug 2014 | Human Drugs | WL | On file |
| 5 Aug 2009 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
23 Sep 2025
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by June P Page, Sarah M Gauna
23 Sep 2025
21 CFR 211.165(d)
Acceptance criteria for sampling & testing
Cited by June P Page, Sarah M Gauna
23 Sep 2025
21 CFR 211.192
Investigations of discrepancies, failures
Cited by June P Page, Sarah M Gauna
Investigators
FDA investigators tied to this site in the record.
June P Page1 insp.
Sarah M Gauna1 insp.
Robert J Ham1 insp.
Lisa L Flores1 insp.
Wayne D Mcgrath1 insp.
Mindy M Chou1 insp.
Tiara N Brown-Crosen1 insp.
Shirley J Berryman1 insp.
Cody D Rickman1 insp.
Pamela L Vega1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.165(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.28(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.46(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.65(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 1x |
| FDCA 503B(a)(10) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Park Avenue Compounding's 6 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat