Overview
- 9 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-10-30.
At a glance
Inspections
9
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 21 Oct 2024 – 30 Oct 2024 | Human Drugs | 483 | View 483 → |
| 16 Oct 2023 – 26 Oct 2023 | Human Drugs | 483 | View 483 → |
| 21 Aug 2019 – 23 Aug 2019 | Human Drugs | 483 | View 483 → |
| 13 Feb 2017 – 16 Feb 2017 | Human Drugs | 483 | View 483 → |
| 10 May 2016 – 12 May 2016 | Animal Drugs & Feeds | 483 | View 483 → |
| 1 Apr 2014 | Animal Drugs & Feeds | Clean | |
| 18 Nov 2011 | Not recorded | Clean | |
| 6 Feb 2009 | Not recorded | Clean | |
| 14 Feb 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
30 Oct 2024
21 CFR 211.103
Actual vs. theoretical yields not determined
Cited by Darren S Brown, Lena Nguyen
30 Oct 2024
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Darren S Brown, Lena Nguyen
30 Oct 2024
21 CFR 211.22(a)
Authority lacking to review records, investigate errors
Cited by Darren S Brown, Lena Nguyen
Investigators
FDA investigators tied to this site in the record.
Darren S Brown3 insp.
Michael D Garcia2 insp.
Lena Nguyen1 insp.
Anney Lin1 insp.
Santiago Gallardo Johnson1 insp.
Yvins Dezan1 insp.
Zachary A Bogorad1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.84(d)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.103 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.115(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.125(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.165(f) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.180(e)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.186(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.194(a)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.142 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.184(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Morgan Gallacher's 5 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