American Pharmaceutical Ingredients LLC
FDA inspection history in Waterford, Michigan, 2017
- 1
- Form 483
Every document, by year
- Form 483
2017: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017One Form 483, at Waterford, Michigan.
Cited most
Across all American Pharmaceutical Ingredients observations on file
- 21 CFR 211.192Production record review3
- 21 CFR 211.180General requirements2
- 21 CFR 211.22Responsibilities of quality control unit2
- 21 CFR 211.160General requirements1
- 21 CFR 211.166Stability testing1
The complete American Pharmaceutical Ingredients file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Waterford, Michigan
One Form 483 · 2017 · 14 observations
Latest: Form 483, Dec 14, 2017 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2017-12-14 | 483 Form 483 | Waterford, Michigan | 14 | $99 |
Investigators on these documents
FEI number 3010302040 · most recent document Dec 14, 2017
About American Pharmaceutical Ingredients LLC
How many FDA Form 483s has American Pharmaceutical Ingredients LLC received?
FDA Intel has 1 Form 483 on file for American Pharmaceutical Ingredients LLC; the most recent is dated Dec 14, 2017.
When was American Pharmaceutical Ingredients LLC last inspected by FDA?
The most recent FDA inspection document on file for American Pharmaceutical Ingredients LLC is a Form 483 dated Dec 14, 2017, for the site in Waterford, Michigan.
What did FDA cite at American Pharmaceutical Ingredients LLC?
The regulations cited most in the observations on file for American Pharmaceutical Ingredients LLC are 21 CFR 211.192 (Production record review), 3 times; 21 CFR 211.180 (General requirements), 2 times; 21 CFR 211.22 (Responsibilities of quality control unit), 2 times.