Overview
- 4 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-11-21.
At a glance
Inspections
4
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 17 Nov 2025 – 21 Nov 2025 | Human Drugs | Clean | |
| 2 Jun 2021 – 4 Jun 2021 | Human Drugs | 483 | On file |
| 5 Nov 2018 – 9 Nov 2018 | Human Drugs | 483 | View 483 → |
| 16 Jul 2018 – 19 Jul 2018 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
9 Nov 2018
21 CFR 211.113(a)
Procedures for non-sterile drug products
Cited by Sandra A Hughes, Sandra A Boyd
9 Nov 2018
21 CFR 211.165(c)
Sampling and testing plans not described
Cited by Sandra A Hughes, Sandra A Boyd
9 Nov 2018
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Sandra A Hughes, Sandra A Boyd
9 Nov 2018
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Sandra A Hughes, Sandra A Boyd
Investigators
FDA investigators tied to this site in the record.
JeanClaude Garay1 insp.
Norman K Starks1 insp.
Sandra A Hughes1 insp.
Sandra A Boyd1 insp.
Christopher D Leach1 insp.
Cassandra L Abellard1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.130 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.165(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.166(a)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Agnitio Inc's 3 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