Overview
- 15 FDA inspections are on record.
- 9 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-05-21.
At a glance
Inspections
15
Form 483s
9
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 19 May 2026 – 21 May 2026 | Human Drugs | 483 | On file |
| 15 Dec 2022 – 22 Dec 2022 | Human Drugs | 483 | On file |
| 14 May 2018 – 17 May 2018 | Human Drugs | 483 | View 483 → |
| 1 Mar 2017 – 5 Apr 2017 | Foods & Cosmetics | 483 | View 483 → |
| 25 Feb 2015 – 12 Mar 2015 | Human Drugs | 483 | View 483 → |
| 5 Jun 2012 | Not recorded | 483 | View 483 → |
| 10 Aug 2011 | Not recorded | 483 | View 483 → |
| 26 Apr 2010 | Not recorded | 483 | View 483 → |
| 25 Jan 2010 | Not recorded | 483 | On file |
| 26 Feb 2009 | Not recorded | Clean | |
| 6 Mar 2007 | Not recorded | Clean | |
| 29 Jun 2005 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
17 May 2018
21 CFR 211.68(b)
Computer control of master formula records
Cited by Santiago Gallardo Johnson
Investigators
FDA investigators tied to this site in the record.
John A Gonzalez2 insp.
Rowena S Nguyen1 insp.
Maurine Fadlalla1 insp.
Journey V Cordero1 insp.
Cecilia H Kieu1 insp.
Santiago Gallardo Johnson1 insp.
Patricia F Alberico1 insp.
Marcus F Yambot1 insp.
Zachary A Bogorad1 insp.
Alexandra B Pitkin1 insp.
Babajide M Osunsanmi1 insp.
Cntrctmntr Kelley1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(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 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.65(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| FDCA 601(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind PLZ Corp's 9 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