Overview
- 6 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-12-09.
At a glance
Inspections
6
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 5 Dec 2022 – 9 Dec 2022 | Foods & Cosmetics | 483 | View 483 → |
| 18 Jun 2019 – 20 Jun 2019 | Foods & Cosmetics | 483 | View 483 → |
| 7 Nov 2016 – 9 Nov 2016 | Foods & Cosmetics | Clean | |
| 5 Feb 2014 – 6 Feb 2014 | Foods & Cosmetics | Clean | |
| 30 May 2012 | Not recorded | 483 | View 483 → |
| 2 Mar 2011 | Not recorded | WL | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
9 Dec 2022
21 CFR 111.205(b)(2)
Master manufacturing record - controls, procedures
Cited by Joseph F Owens
9 Dec 2022
21 CFR 111.205(b)(2)
Master manufacturing record - controls, procedures
Cited by Joseph F Owens
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 111.205(b)(2) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 111.255(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.14(b)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.205(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.255(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.355 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.503 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.105(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.12(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.123(a)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.135 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.15(f)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.153 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.155(d)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.20(c)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.20(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.27(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.375(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.515 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(a)(1)(i) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site's 4 Form 483s
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