Overview
- 8 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-05-16.
At a glance
Inspections
8
Form 483s
5
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 9 May 2022 – 16 May 2022 | Human Drugs | 483 | View 483 → |
| 7 Jan 2016 – 8 Jan 2016 | Human Drugs | Clean | |
| 12 Nov 2013 – 15 Nov 2013 | Human Drugs | 483 | View 483 → |
| 21 Jun 2011 | Not recorded | 483 | View 483 → |
| 20 May 2010 | Not recorded | 483 | View 483 → |
| 20 Feb 2009 | Not recorded | Clean | |
| 17 Mar 2008 | Not recorded | 483 | On file |
| 27 Oct 2006 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Sony Mathews2 insp.
Rachael O Oyewole1 insp.
James A Liubicich1 insp.
Satheesh Thomas1 insp.
Jacqueline S Warner1 insp.
Demitria J Xiradakis1 insp.
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 | 2x |
| 21 CFR 211.125(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.130(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.170(b) | 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 211.115(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.122(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.125(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.125(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.130 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.130(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.130(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.130(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.184(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(c) | 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 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Premier Brands of America Inc'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