Overview
- 12 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-02-19.
At a glance
Inspections
12
Form 483s
7
EIRs
3
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 5 Feb 2025 – 19 Feb 2025 | Human Drugs | 483 | On file |
| 8 Feb 2023 – 24 Mar 2023 | Human Drugs | 483 | On file |
| 1 Jun 2021 – 14 Jul 2021 | Human Drugs | 483 | On file |
| 19 Feb 2019 – 12 Mar 2019 | Human Drugs | WL | On file |
| 1 Mar 2016 – 14 Mar 2016 | Human Drugs | 483 | On file |
| 6 Aug 2013 – 16 Aug 2013 | Human Drugs | 483 | On file |
| 2 Dec 2011 | Not recorded | 483 | On file |
| 29 Jun 2011 | Not recorded | Clean | |
| 11 Aug 2010 | Not recorded | Clean | |
| 20 Mar 2008 | Not recorded | Clean | |
| 21 Jun 2002 | Not recorded | Clean | |
| 10 May 2002 | Not recorded | Clean |
Investigators
FDA investigators tied to this site in the record.
Anthony J Donato1 insp.
Robin P Mathew1 insp.
Barbara J Wilimczyk-Macri1 insp.
Sayyem H Akbar1 insp.
Elaine E Gilfillan1 insp.
James R Birkenstamm1 insp.
Ankur C Patel1 insp.
Emmanuel J Ramos1 insp.
Adetutu M Gidado1 insp.
Nancy M Espinal1 insp.
Maria Estrella1 insp.
Frederick Razzaghi1 insp.
Nicholas A Violand1 insp.
Sarah M Forney1 insp.
Addam S Reynolds1 insp.
Joy R Klena1 insp.
Full site report
Get the verbatim findings behind this site's 7 Form 483s
The full inspection record, as Atlas holds it, 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