Overview
- 10 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-08-13.
At a glance
Inspections
10
Form 483s
4
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 8 Aug 2025 – 13 Aug 2025 | Foods & Cosmetics | Clean | |
| 23 Aug 2023 – 1 Sep 2023 | Human Drugs | 483 | View 483 → |
| 6 Jun 2018 – 13 Jun 2018 | Human Drugs | Clean | |
| 22 May 2015 – 8 Jun 2015 | Human Drugs | 483 | View 483 → |
| 3 Jan 2013 | Not recorded | 483 | View 483 → |
| 13 Jul 2009 | Not recorded | Clean | |
| 1 Aug 2008 | Not recorded | WL | On file |
| 3 Aug 2006 | Not recorded | Clean | |
| 27 Jun 2005 | Not recorded | Clean | |
| 29 Nov 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
1 Sep 2023
21 CFR 211.115(b)
Reprocessing/quality control unit
Cited by Simone E Pitts, Martrice A Packer
1 Sep 2023
21 CFR 211.115(b)
Reprocessing/quality control unit
Cited by Simone E Pitts, Martrice A Packer
1 Sep 2023
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Simone E Pitts, Martrice A Packer
Investigators
FDA investigators tied to this site in the record.
Joanne E King3 insp.
Benita C Okeke1 insp.
Simone E Pitts1 insp.
Martrice A Packer1 insp.
Karen M Rodriguez1 insp.
German Rivera1 insp.
Ileana Barreto-Pettit1 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 | 5x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.115(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.111 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Prime Enterprises LLC's 4 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