Overview
- 7 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2023-07-21.
At a glance
Inspections
7
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 17 Jul 2023 – 21 Jul 2023 | Human Drugs | 483 | View 483 → |
| 27 Nov 2017 – 30 Nov 2017 | Human Drugs | Clean | |
| 25 Jul 2016 – 29 Jul 2016 | Human Drugs | Clean | |
| 19 Feb 2014 – 24 Feb 2014 | Human Drugs | Clean | |
| 25 Sep 2012 | Not recorded | Clean | |
| 4 Mar 2011 | Not recorded | Clean | |
| 21 Mar 2008 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
21 Jul 2023
21 CFR 211.42(c)(1)
Incoming material area
Cited by Harshal J Desai, Regan T Harp, Megan T Ziegler
21 Jul 2023
21 CFR 211.80(a)
Written Procedures Not Followed
Cited by Harshal J Desai, Regan T Harp, Megan T Ziegler
Investigators
FDA investigators tied to this site in the record.
Tracy R Ball3 insp.
Harshal J Desai1 insp.
Regan T Harp1 insp.
Megan T Ziegler1 insp.
Jared P Stevens1 insp.
Constance Y Fears1 insp.
Eileen J Bannerman1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.42(c)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Cosette Pharmaceuticals NC Laboratories, LLC's 1 Form 483
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