Overview
- 8 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-03-20.
At a glance
Inspections
8
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 Mar 2025 – 20 Mar 2025 | Human Drugs | 483 | View 483 → |
| 13 Sep 2021 – 22 Sep 2021 | Human Drugs | 483 | On file |
| 24 Jun 2019 – 28 Jun 2019 | Foods & Cosmetics | Clean | |
| 9 Nov 2015 – 30 Nov 2015 | Human Drugs | WL | On file |
| 21 Jun 2012 | Not recorded | 483 | On file |
| 14 Aug 2008 | Not recorded | 483 | On file |
| 12 May 2006 | Not recorded | Clean | |
| 12 Sep 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
20 Mar 2025
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Damaris Y Hernandez, Michael Z Weigman
20 Mar 2025
21 CFR 211.192
Quality control unit review of records
Cited by Damaris Y Hernandez, Michael Z Weigman
20 Mar 2025
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Damaris Y Hernandez, Michael Z Weigman
20 Mar 2025
21 CFR 211.63
Equipment Design, Size and Location
Cited by Damaris Y Hernandez, Michael Z Weigman
20 Mar 2025
21 CFR 211.67(b)(2)
Cleaning SOPs/schedules
Cited by Damaris Y Hernandez, Michael Z Weigman
Investigators
FDA investigators tied to this site in the record.
Damaris Y Hernandez1 insp.
Michael Z Weigman1 insp.
Nicole E Knowlton1 insp.
Jason P Aun1 insp.
Ileana Barreto-Pettit1 insp.
Angela E Glenn1 insp.
Barbara T Carmichael1 insp.
Kelly I Anderson1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.117(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.14(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.15(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.205(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.255(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(l)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.35(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.35(b)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.503 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.95(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.95(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Pharmco Laboratories Inc.'s 5 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