Overview
- 8 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-08-15.
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 |
|---|---|---|---|
| 4 Aug 2025 – 15 Aug 2025 | Human Drugs | 483 | View 483 → |
| 5 Mar 2025 – 7 Mar 2025 | Foods & Cosmetics | Clean | |
| 4 May 2023 – 9 May 2023 | Foods & Cosmetics | Clean | |
| 26 Mar 2018 – 9 Apr 2018 | Human Drugs | 483 | On file |
| 22 Aug 2016 – 26 Aug 2016 | Human Drugs | 483 | On file |
| 16 Aug 2012 | Not recorded | 483 | On file |
| 12 Aug 2010 | Not recorded | 483 | On file |
| 2 Nov 2007 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
15 Aug 2025
21 CFR 211.113(a)
Procedures for non-sterile drug products
Cited by Shelby N Turner, Mercedes N Overton
15 Aug 2025
21 CFR 211.130(a)
Prevention of cross contamination, mix-ups
Cited by Shelby N Turner, Mercedes N Overton
15 Aug 2025
21 CFR 211.165(f)
Failing drug products not rejected
Cited by Shelby N Turner, Mercedes N Overton
15 Aug 2025
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Shelby N Turner, Mercedes N Overton
15 Aug 2025
21 CFR 211.198(b)(2)
Complaint Investigation/Follow-Up Findings
Cited by Shelby N Turner, Mercedes N Overton
Investigators
FDA investigators tied to this site in the record.
Adrian Rodriguez2 insp.
Shelby N Turner1 insp.
Mercedes N Overton1 insp.
Ninfa N Innocent1 insp.
Jessica A Isaac1 insp.
Liza L Quiles1 insp.
Nimmy Mathews1 insp.
Shelby N Marler1 insp.
Patrice S Hall1 insp.
Jodi M Gatica1 insp.
Trina K Vick1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.75(a)(1)(i) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.180(e)(2) | Cited across public-safe Form 483 observations | 2x |
| 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 |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.123(a)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.14(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.160(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.165(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.205(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.25(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(j)(2)(ii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.30(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.30(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.365(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.553 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.60(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.130 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.130(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(4) | 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 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.182 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b)(3) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind United Laboratories Manufacturing, LLC'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