Intact Pharmaceuticals LLC
FDA inspection history in New Milford, Connecticut, 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 New Milford, Connecticut.
Cited most
Across all Intact Pharmaceuticals observations on file
- 21 CFR 211.42Design and construction features3
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.192Production record review1
- 21 CFR 211.22Responsibilities of quality control unit1
- 21 CFR 211.25Personnel qualifications1
The complete Intact Pharmaceuticals file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
New Milford, Connecticut
One Form 483 · 2018 · 11 observations
Latest: Form 483, Oct 12, 2018 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2018-10-12 | 483 Form 483 | New Milford, Connecticut | 11 | $99 |
Investigators on these documents
FEI number 3014184709 · most recent document Oct 12, 2018
About Intact Pharmaceuticals LLC
How many FDA Form 483s has Intact Pharmaceuticals LLC received?
FDA Intel has 1 Form 483 on file for Intact Pharmaceuticals LLC; the most recent is dated Oct 12, 2018.
When was Intact Pharmaceuticals LLC last inspected by FDA?
The most recent FDA inspection document on file for Intact Pharmaceuticals LLC is a Form 483 dated Oct 12, 2018, for the site in New Milford, Connecticut.
What did FDA cite at Intact Pharmaceuticals LLC?
The regulations cited most in the observations on file for Intact Pharmaceuticals LLC are 21 CFR 211.42 (Design and construction features), 3 times; 21 CFR 211.113 (Control of microbiological contamination), 2 times; 21 CFR 211.192 (Production record review), 1 time.