Premier Pharmacy Labs Inc.
FDA inspection history across 2 sites, 2014 to 2020
- 3
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2014: one Form 483; 2015: one warning letter; 2016: one Form 483; 2020: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2014–16Two Form 483s and one warning letter, at WEEKI WACHEE, Florida and Weeki Wachee, Florida.
- 2020One Form 483, at Weeki Wachee, Florida.
- 2020The longest 483 on file: 16 observations over 17 pages at Weeki Wachee, Florida.
Cited most
Across all Premier Pharmacy Labs observations on file
- 21 CFR 211.42Design and construction features12
- 21 CFR 211.113Control of microbiological contamination5
- 21 CFR 211.192Production record review4
- 21 CFR 211.166Stability testing3
- 21 CFR 211.165Testing and release for distribution2
The complete Premier Pharmacy Labs file.
All 4 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Weeki Wachee, Florida
One Form 483 and one warning letter · 2015 to 2020 · 16 observations
Latest: Form 483, Apr 29, 2020 →WEEKI WACHEE, Florida
Two Form 483s · 2014 to 2016 · 26 observations
Latest: Form 483, Jun 13, 2016 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2020-04-29 | 483 Form 483 | Weeki Wachee, Florida | 16 | $99 |
| 2016-06-13 | 483 Form 483 | WEEKI WACHEE, Florida | 11 | $99 |
| 2015-04-27 | Warning letter Warning letter | Weeki Wachee, Florida | — | $99 |
| 2014-05-09 | 483 Form 483 | WEEKI WACHEE, Florida | 15 | $99 |
Investigators on these documents
Djamila Harouaka (1)Ileana Barreto-Pettit (1)Joanne E. King (1)Michael H. Tollon (1)Noreen Muniz (1)
FEI number 3007271263 · most recent document Apr 29, 2020
About Premier Pharmacy Labs Inc.
How many FDA Form 483s has Premier Pharmacy Labs Inc. received?
FDA Intel has 3 Form 483s on file for Premier Pharmacy Labs Inc.; the most recent is dated Apr 29, 2020.
When was Premier Pharmacy Labs Inc. last inspected by FDA?
The most recent FDA inspection document on file for Premier Pharmacy Labs Inc. is a Form 483 dated Apr 29, 2020, for the site in Weeki Wachee, Florida.
What did FDA cite at Premier Pharmacy Labs Inc.?
The regulations cited most in the observations on file for Premier Pharmacy Labs Inc. are 21 CFR 211.42 (Design and construction features), 12 times; 21 CFR 211.113 (Control of microbiological contamination), 5 times; 21 CFR 211.192 (Production record review), 4 times.
Has Premier Pharmacy Labs Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Premier Pharmacy Labs Inc.; the most recent is dated Apr 27, 2015.