Pentec Health, Inc.
FDA inspection history in Boothwyn, Pennsylvania, 2013 to 2014
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2013: one Form 483; 2014: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2013–14One Form 483 and one warning letter, at Boothwyn, Pennsylvania.
Cited most
Across all Pentec Health observations on file
- 21 CFR 211.42(a)Design and construction features2
- 21 CFR 211.113(b)Control of microbiological contamination1
- 21 CFR 211.165(c)Testing and release for distribution1
- 21 CFR 211.166(a)Stability testing1
- 21 CFR 211.192Production record review1
The complete Pentec Health 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
Boothwyn, Pennsylvania
One warning letter and one Form 483 · 2013 to 2014 · 9 observations
Latest: Warning letter, Mar 7, 2014 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2014-03-07 | Warning letter Warning letter | Boothwyn, Pennsylvania | — | $99 |
| 2013-04-01 | 483 Form 483 | Boothwyn, Pennsylvania | 9 | $99 |
Investigators on these documents
FEI number 3006489293 · most recent document Mar 7, 2014
About Pentec Health, Inc.
How many FDA Form 483s has Pentec Health, Inc. received?
FDA Intel has 1 Form 483 on file for Pentec Health, Inc.; the most recent is dated Apr 1, 2013.
When was Pentec Health, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Pentec Health, Inc. is a Form 483 dated Apr 1, 2013, for the site in Boothwyn, Pennsylvania.
What did FDA cite at Pentec Health, Inc.?
The regulations cited most in the observations on file for Pentec Health, Inc. are 21 CFR 211.42(a) (Design and construction features), 2 times; 21 CFR 211.113(b) (Control of microbiological contamination), 1 time; 21 CFR 211.165(c) (Testing and release for distribution), 1 time.
Has Pentec Health, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Pentec Health, Inc.; the most recent is dated Mar 7, 2014.