Pentec Health
FDA inspection history in Boothwyn, Pennsylvania, 2018
- 1
- Form 483
Every document, by year
- Form 483
2018: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2018One Form 483, at Boothwyn, Pennsylvania.
Cited most
Across all Pentec Health observations on file
- 21 CFR 211.111Time limitations on production1
- 21 CFR 211.188Batch production and control records1
- 21 CFR 211.22(d)Responsibilities of quality control unit1
- 21 CFR 211.42(c)(10)(iv)Design and construction features1
- 21 CFR 211.67(b)Equipment cleaning and maintenance1
The complete Pentec Health file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Boothwyn, Pennsylvania
One Form 483 · 2018 · 5 observations
Latest: Form 483, Feb 23, 2018 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2018-02-23 | 483 Form 483 | Boothwyn, Pennsylvania | 5 | $99 |
Investigators on these documents
FEI number 3012746140 · most recent document Feb 23, 2018
About Pentec Health
How many FDA Form 483s has Pentec Health received?
FDA Intel has 1 Form 483 on file for Pentec Health; the most recent is dated Feb 23, 2018.
When was Pentec Health last inspected by FDA?
The most recent FDA inspection document on file for Pentec Health is a Form 483 dated Feb 23, 2018, for the site in Boothwyn, Pennsylvania.
What did FDA cite at Pentec Health?
The regulations cited most in the observations on file for Pentec Health are 21 CFR 211.111 (Time limitations on production), 1 time; 21 CFR 211.188 (Batch production and control records), 1 time; 21 CFR 211.22(d) (Responsibilities of quality control unit), 1 time.