Overview
- 23 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-12-17.
At a glance
Inspections
23
Form 483s
8
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 4 Dec 2025 – 17 Dec 2025 | Human Drugs | 483 | View 483 → |
| 19 Aug 2024 – 28 Aug 2024 | Human Drugs | Clean | |
| 7 Mar 2022 – 13 Apr 2022 | Human Drugs | 483 | On file |
| 9 Mar 2017 – 17 Mar 2017 | Human Drugs | 483 | On file |
| 14 Oct 2014 – 31 Oct 2014 | Biologics | 483 | On file |
| 24 Oct 2012 | Not recorded | 483 | On file |
| 18 Jul 2012 | Not recorded | Clean | |
| 1 Oct 2010 | Not recorded | 483 | On file |
| 23 Oct 2009 | Not recorded | Clean | |
| 24 Jul 2009 | Not recorded | Clean | |
| 1 Jul 2009 | Not recorded | Clean | |
| 8 Oct 2008 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
17 Dec 2025
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Anthony J Donato, Amatul H Marium, Luxuly Abraham
17 Dec 2025
21 CFR 211.194(a)(2)
Laboratory Test Method Verification
Cited by Anthony J Donato, Amatul H Marium, Luxuly Abraham
17 Dec 2025
21 CFR 211.84(b)
Representative Samples Criteria
Cited by Anthony J Donato, Amatul H Marium, Luxuly Abraham
17 Dec 2025
21 CFR 211.84(d)(6)
Microbiological Contamination Exam
Cited by Anthony J Donato, Amatul H Marium, Luxuly Abraham
Investigators
FDA investigators tied to this site in the record.
Anthony J Donato2 insp.
Susan M Jackson2 insp.
Nancy T Waites2 insp.
Amatul H Marium1 insp.
Luxuly Abraham1 insp.
Anastasia M Shields1 insp.
Ogechi C Nna1 insp.
Lata C Mathew1 insp.
Yvins Dezan1 insp.
Kristina L Conroy1 insp.
Diane L Raccasi1 insp.
Wayne E Seifert1 insp.
Maria J Lopez- Barragan1 insp.
Jacqueline M Diaz Albert1 insp.
Prabhu P Raju1 insp.
Amber D Brodas1 insp.
Helen B Ricalde1 insp.
Kevin A Gonzalez1 insp.
Sarah B Tanksley1 insp.
Lori P Peters1 insp.
Martha T Olone1 insp.
Karen L Kosar1 insp.
Jacqueline S Warner1 insp.
Mihaly S Ligmond1 insp.
Paul C Mouris1 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 | 1x |
| 21 CFR 211.194(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(b) | 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 this site's 8 Form 483s
Source PDFs 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