Overview
- 11 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-07-02.
At a glance
Inspections
11
Form 483s
6
EIRs
2
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 1 Jul 2024 – 2 Jul 2024 | Human Drugs | Clean | |
| 22 Mar 2023 – 31 Mar 2023 | Human Drugs | Clean | |
| 27 Apr 2021 – 4 May 2021 | Human Drugs | 483 | View 483 → |
| 1 May 2018 – 8 May 2018 | Human Drugs | 483 | On file |
| 19 Dec 2017 – 11 Jan 2018 | Human Drugs | 483 | View 483 → |
| 9 Feb 2015 – 13 Feb 2015 | Human Drugs | 483 | On file |
| 20 Nov 2013 – 4 Dec 2013 | Human Drugs | 483 | View 483 → |
| 30 Nov 2011 | Not recorded | 483 | View 483 → |
| 8 Apr 2010 | Not recorded | Clean | |
| 3 Mar 2005 | Not recorded | Clean | |
| 6 Sep 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
4 May 2021
21 CFR 211.67(c)
Cleaning/maintenance records not kept
Cited by Russell J Glapion, Ankur C Patel
4 May 2021
21 CFR 211.67(c)
Cleaning/maintenance records not kept
Cited by Russell J Glapion, Ankur C Patel
Investigators
FDA investigators tied to this site in the record.
Ankur C Patel2 insp.
Russell J Glapion2 insp.
Paul L Bellamy2 insp.
Syeda N Mahazabin1 insp.
Catherine O Lamptey1 insp.
Olumide A Akinyemi1 insp.
Frederick Razzaghi1 insp.
Tamil Arasu1 insp.
Unnee Ranjan1 insp.
Barbara J Wilimczyk-Macri1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.111 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(9) | 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)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind CMIC CMO USA Corporation's 6 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