Overview
- 11 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-10-16.
At a glance
Inspections
11
Form 483s
8
EIRs
3
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 29 Sep 2025 – 16 Oct 2025 | Human Drugs | WL | View 483 → |
| 28 Jun 2023 – 13 Jul 2023 | Human Drugs | 483 | View 483 → |
| 24 Feb 2020 – 13 Mar 2020 | Human Drugs | 483 | View 483 → |
| 2 Oct 2017 – 12 Oct 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 14 Jul 2015 – 21 Jul 2015 | Human Drugs | 483 | View 483 → |
| 14 Jan 2014 – 24 Feb 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 13 Jul 2011 | Not recorded | Clean | |
| 27 Apr 2011 | Not recorded | 483 | View 483 → |
| 14 Jun 2010 | Not recorded | 483 | View 483 → |
| 18 Dec 2007 | Not recorded | Clean | |
| 29 Oct 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
16 Oct 2025
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Anastasia M Shields, Christina K Theodorou
16 Oct 2025
21 CFR 211.113(a)
Procedures for non-sterile drug products
Cited by Anastasia M Shields, Christina K Theodorou
16 Oct 2025
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Anastasia M Shields, Christina K Theodorou
16 Oct 2025
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Anastasia M Shields, Christina K Theodorou
16 Oct 2025
21 CFR 211.165(b)
Microbiological testing
Cited by Anastasia M Shields, Christina K Theodorou
Investigators
FDA investigators tied to this site in the record.
Christina K Theodorou2 insp.
Anastasia M Shields1 insp.
Daniel J Min1 insp.
Allison A Aldridge1 insp.
Rachael O Oyewole1 insp.
Michael A Taylor1 insp.
Sam Pepe1 insp.
Alison N Stieg1 insp.
Junho Pak1 insp.
Raffi B Papazian1 insp.
Deborah J Parris1 insp.
Gayle S Lawson1 insp.
Kendra L Brooks1 insp.
Anita R Michael1 insp.
Thomas E Friel1 insp.
Vlada Matusovsky1 insp.
Michael J Nerz1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 10x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 7x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.194(a)(3) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.194(a)(4) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.194(a)(8) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.194(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.67(b)(3) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.89 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.560(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | 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 211.188(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Medical Products Laboratories, Inc.'s 8 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