Amphastar Pharmaceuticals, Inc.
FDA inspection history in Rancho Cucamonga, California, 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 Rancho Cucamonga, California.
Cited most
Across all Amphastar Pharmaceuticals observations on file
- 21 CFR 820.30Design controls5
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.22Responsibilities of quality control unit2
- 21 CFR 211.160General requirements1
The complete Amphastar Pharmaceuticals file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Rancho Cucamonga, California
One Form 483 · 2017 · 20 observations
Latest: Form 483, Mar 31, 2017 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2017-03-31 | 483 Form 483 | Rancho Cucamonga, California | 20 | $99 |
Investigators on these documents
Carrie A. Hughes (1)Jeffrey P. Raimondi (1)Marcus F. Yambot (1)Sonya L. Karsik (1)
About Amphastar Pharmaceuticals, Inc.
How many FDA Form 483s has Amphastar Pharmaceuticals, Inc. received?
FDA Intel has 1 Form 483 on file for Amphastar Pharmaceuticals, Inc.; the most recent is dated Mar 31, 2017.
When was Amphastar Pharmaceuticals, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Amphastar Pharmaceuticals, Inc. is a Form 483 dated Mar 31, 2017, for the site in Rancho Cucamonga, California.
What did FDA cite at Amphastar Pharmaceuticals, Inc.?
The regulations cited most in the observations on file for Amphastar Pharmaceuticals, Inc. are 21 CFR 820.30 (Design controls), 5 times; 21 CFR 211.100 (Written procedures; deviations), 2 times; 21 CFR 211.113 (Control of microbiological contamination), 2 times.