PharmaLogic CSP, Inc.
FDA inspection history across 2 sites, 2014 to 2016
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2014: one Form 483; 2016: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2014–16One Form 483 and one warning letter, at Bridgep ort, West Virginia and Boca Raton, Florida.
Cited most
Across all PharmaLogic CSP observations on file
- 21 CFR 211.42Design and construction features3
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.137Expiration dating1
- 21 CFR 211.166Stability testing1
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures1
The complete PharmaLogic CSP file.
All 2 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
Boca Raton, Florida
One warning letter · 2016
Latest: Warning letter, Apr 29, 2016 →Bridgep ort, West Virginia
One Form 483 · 2014 · 8 observations
Latest: Form 483, Dec 12, 2014 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2016-04-29 | Warning letter Warning letter | Boca Raton, Florida | — | $99 |
| 2014-12-12 | 483 Form 483 | Bridgep ort, West Virginia | 8 | $99 |
Investigators on these documents
Doan T. Nguyen (1)Mujadala M. Abdul-Majid (1)Rachel C. Harrington (1)
FEI number 3011193301 · most recent document Apr 29, 2016
About PharmaLogic CSP, Inc.
How many FDA Form 483s has PharmaLogic CSP, Inc. received?
FDA Intel has 1 Form 483 on file for PharmaLogic CSP, Inc.; the most recent is dated Dec 12, 2014.
When was PharmaLogic CSP, Inc. last inspected by FDA?
The most recent FDA inspection document on file for PharmaLogic CSP, Inc. is a Form 483 dated Dec 12, 2014, for the site in Bridgep ort, West Virginia.
What did FDA cite at PharmaLogic CSP, Inc.?
The regulations cited most in the observations on file for PharmaLogic CSP, Inc. are 21 CFR 211.42 (Design and construction features), 3 times; 21 CFR 211.113 (Control of microbiological contamination), 2 times; 21 CFR 211.137 (Expiration dating), 1 time.
Has PharmaLogic CSP, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for PharmaLogic CSP, Inc.; the most recent is dated Apr 29, 2016.