Overview
- 9 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-02-13.
At a glance
Inspections
9
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 10 Feb 2025 – 13 Feb 2025 | Human Drugs | 483 | View 483 → |
| 2 Mar 2020 – 5 Mar 2020 | Human Drugs | 483 | View 483 → |
| 20 Jun 2017 – 5 Jul 2017 | Human Drugs | 483 | View 483 → |
| 21 Dec 2010 | Not recorded | Clean | |
| 15 Oct 2008 | Not recorded | 483 | View 483 → |
| 3 Sep 2008 | Not recorded | 483 | On file |
| 17 Nov 2005 | Not recorded | Clean | |
| 28 Mar 2005 | Not recorded | Clean | |
| 23 Apr 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
13 Feb 2025
21 CFR 211.188
Prepared for each batch, include complete information
Cited by Tiara M Brown
5 Mar 2020
21 CFR 211.186(b)(9)
Complete instructions, procedures, specifications et. al.
Cited by Liming Zhang
5 Mar 2020
21 CFR 211.188(b)
Batch production and Batch Control Record Requirements
Cited by Liming Zhang
Investigators
FDA investigators tied to this site in the record.
Tiara M Brown1 insp.
Liming Zhang1 insp.
Jolanna A Norton1 insp.
Ayodele I Ojediran1 insp.
Joey V Quitania1 insp.
Virgilio F Pacio1 insp.
Cntrctmntr Kelley1 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 | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(13) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(5) | 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 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind MCKENNA LABS, 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