Overview
- 6 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-01-11.
At a glance
Inspections
6
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 8 Jan 2024 – 11 Jan 2024 | Animal Drugs & Feeds | 483 | View 483 → |
| 15 Nov 2012 | Not recorded | Clean | |
| 2 Sep 2008 | Not recorded | 483 | On file |
| 28 Aug 2006 | Not recorded | Clean | |
| 9 Dec 2004 | Not recorded | Clean | |
| 30 May 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
11 Jan 2024
21 CFR 211.165(a)
Testing and release for distribution
Cited by Alan A Rivera, Megan T Ziegler
11 Jan 2024
21 CFR 211.166(a)
Lack of written stability program
Cited by Alan A Rivera, Megan T Ziegler
11 Jan 2024
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Alan A Rivera, Megan T Ziegler
11 Jan 2024
21 CFR 211.42(c)
Defined areas of adequate size for operations
Cited by Alan A Rivera, Megan T Ziegler
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Custom Manufacturing Corporation's 2 Form 483s
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