Overview
- 8 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-05-01.
At a glance
Inspections
8
Form 483s
2
EIRs
2
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 27 Apr 2026 – 1 May 2026 | Human Drugs | Clean | |
| 10 Apr 2023 – 13 Apr 2023 | Human Drugs | Clean | |
| 22 May 2017 – 25 May 2017 | Human Drugs | 483 | View 483 → |
| 29 Nov 2016 – 2 Dec 2016 | Human Drugs | Clean | |
| 12 Jan 2015 – 20 Jan 2015 | Human Drugs | 483 | View 483 → |
| 28 Jul 2011 | Not recorded | Clean | |
| 15 Nov 2010 | Not recorded | Clean | |
| 9 Mar 2009 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
25 May 2017
21 CFR 211.160(b)(4)
Establishment of calibration procedures
Cited by James M Mason, Christina K Theodorou, Ko U Min
Investigators
FDA investigators tied to this site in the record.
James M Mason2 insp.
Vlada Matusovsky2 insp.
Olumide A Akinyemi1 insp.
Syeda N Mahazabin1 insp.
Christina K Theodorou1 insp.
Ko U Min1 insp.
Anita R Michael1 insp.
Kendra L Brooks1 insp.
Shirley J Berryman1 insp.
Cynthia A Palmer1 insp.
Julianne C Mccullough1 insp.
Maria A Reed1 insp.
Hala L Selby1 insp.
Todd J Maushart1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site's 2 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