Overview
- 3 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-06-01.
At a glance
Inspections
3
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 20 Apr 2026 – 1 Jun 2026 | Human Drugs | 483 | View 483 → |
| 25 Mar 2025 – 4 Apr 2025 | Human Drugs | WL | View 483 → |
| 11 Oct 2022 – 27 Oct 2022 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
1 Jun 2026
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Saundrea A Munroe, Michael Z Weigman
1 Jun 2026
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Saundrea A Munroe, Michael Z Weigman
1 Jun 2026
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Saundrea A Munroe, Michael Z Weigman
1 Jun 2026
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Saundrea A Munroe, Michael Z Weigman
1 Jun 2026
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Saundrea A Munroe, Michael Z Weigman
Investigators
FDA investigators tied to this site in the record.
Saundrea A Munroe1 insp.
Michael Z Weigman1 insp.
Jose R Lopez1 insp.
Joanne E King1 insp.
Kayla V Sprague1 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 | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| FDCA 503B(b)(2)(A) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | 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 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind PQ Pharmacy LLC's 3 Form 483s
Source PDFs 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