Overview
- 12 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-04-17.
At a glance
Inspections
12
Form 483s
7
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 17 Apr 2024 | Human Drugs | Clean | |
| 25 Aug 2022 – 2 Sep 2022 | Human Drugs | 483 | View 483 → |
| 9 Jan 2018 – 16 Jan 2018 | Human Drugs | 483 | On file |
| 3 Nov 2017 – 9 Nov 2017 | Human Drugs | Clean | |
| 28 Nov 2016 – 13 Dec 2016 | Human Drugs | 483 | View 483 → |
| 11 May 2015 – 28 May 2015 | Human Drugs | 483 | View 483 → |
| 15 Jun 2012 | Not recorded | 483 | View 483 → |
| 1 Mar 2010 | Not recorded | Clean | |
| 19 Jun 2009 | Not recorded | 483 | View 483 → |
| 31 Mar 2008 | Not recorded | 483 | On file |
| 31 Aug 2007 | Not recorded | Clean | |
| 22 Sep 2004 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
2 Sep 2022
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Nicole E Knowlton, Steven A Brettler, Damaris Y Hernandez
2 Sep 2022
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Nicole E Knowlton, Steven A Brettler, Damaris Y Hernandez
2 Sep 2022
21 CFR 211.56(a)
Sanitation--buildings not clean, free of infestation
Cited by Nicole E Knowlton, Steven A Brettler, Damaris Y Hernandez
13 Dec 2016
21 CFR 211.113(a)
Procedures for non-sterile drug products
Cited by Jessica L Pressley, Ileana Barreto-Pettit
13 Dec 2016
21 CFR 211.165(b)
Microbiological testing
Cited by Jessica L Pressley, Ileana Barreto-Pettit
Investigators
FDA investigators tied to this site in the record.
Nicole E Knowlton2 insp.
Jessica L Pressley2 insp.
Mizanne E Lewis2 insp.
Deborah A Greco1 insp.
Steven A Brettler1 insp.
Damaris Y Hernandez1 insp.
Noreen Muniz1 insp.
Gene R Gunn1 insp.
Ileana Barreto-Pettit1 insp.
Lundy H Patrick1 insp.
Daveta L Bailey1 insp.
Miguel A Martinez1 insp.
Bill Tackett1 insp.
Daryl A Dewoskin1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 8x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.166(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.180(e)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | 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 211.188(b)(12) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | 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(d) | 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 211.80(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(c)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site's 7 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