Overview
- 15 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-04-28.
At a glance
Inspections
15
Form 483s
6
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 14 Apr 2025 – 28 Apr 2025 | Human Drugs | 483 | View 483 → |
| 19 Aug 2024 – 20 Aug 2024 | Human Drugs | Clean | |
| 16 Jan 2024 – 26 Jan 2024 | Human Drugs | 483 | View 483 → |
| 18 Mar 2019 – 26 Mar 2019 | Human Drugs | 483 | View 483 → |
| 27 Mar 2017 – 31 Mar 2017 | Human Drugs | 483 | View 483 → |
| 26 Mar 2014 – 27 Mar 2014 | Human Drugs | Clean | |
| 28 May 2013 – 31 May 2013 | Human Drugs | Clean | |
| 16 Aug 2012 | Not recorded | Clean | |
| 24 Aug 2011 | Not recorded | 483 | View 483 → |
| 2 Jun 2010 | Not recorded | WL | View 483 → |
| 23 Mar 2007 | Not recorded | Clean | |
| 23 Mar 2006 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
28 Apr 2025
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Walden H Lee, Cecilia H Kieu, Jay-Ar C Bendo
28 Apr 2025
21 CFR 211.192
No written record of investigation
Cited by Walden H Lee, Cecilia H Kieu, Jay-Ar C Bendo
28 Apr 2025
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Walden H Lee, Cecilia H Kieu, Jay-Ar C Bendo
28 Apr 2025
21 CFR 211.67(b)
Written procedures not established/followed
Cited by Walden H Lee, Cecilia H Kieu, Jay-Ar C Bendo
26 Jan 2024
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Michael T Cyrus, Crystal Monroy, Heidy C Perales, Pearl C Ozuruigbo
Investigators
FDA investigators tied to this site in the record.
Jennifer M Gogley4 insp.
Caryn M Mcnab2 insp.
Walden H Lee1 insp.
Cecilia H Kieu1 insp.
Jay-Ar C Bendo1 insp.
Iris C Macinnes1 insp.
Michael T Cyrus1 insp.
Crystal Monroy1 insp.
Heidy C Perales1 insp.
Pearl C Ozuruigbo1 insp.
Nayan J Patel1 insp.
Bryan A Galvez1 insp.
Yasamin Ameri1 insp.
Yvins Dezan1 insp.
Joey V Quitania1 insp.
Linda Thai1 insp.
Virgilio F Pacio1 insp.
Uttaniti Limchumroon1 insp.
Diane C Van Leeuwen1 insp.
Maria C Fermin1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.111 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.122(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(3) | 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 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(vi) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(6) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind McGuff Pharmaceuticals, Inc.'s 6 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