Overview
- 3 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-06-12.
At a glance
Inspections
3
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 29 Apr 2019 – 12 Jun 2019 | Human Drugs | 483 | View 483 → |
| 6 Jun 2016 – 13 Jun 2016 | Human Drugs | 483 | On file |
| 10 Apr 2014 – 9 May 2014 | Human Drugs | WL | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
12 Jun 2019
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Joanne E King, Djamila Harouaka
12 Jun 2019
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Joanne E King, Djamila Harouaka
12 Jun 2019
21 CFR 211.166(a)
Results not used for expiration dates, storage cond.
Cited by Joanne E King, Djamila Harouaka
Investigators
FDA investigators tied to this site in the record.
Joanne E King1 insp.
Djamila Harouaka1 insp.
Noreen Muniz1 insp.
Ileana Barreto-Pettit1 insp.
Michael H Tollon1 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 | 3x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.167(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(iii) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(b) | 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 211.28(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(ii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.94(d) | Cited across public-safe Form 483 observations | 1x |
| FDCA 501(a)(2)(A) | Cited across public-safe Form 483 observations | 1x |
| FDCA 503B(a)(10) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Premier Pharmacy Labs Inc's 3 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