Amphastar Pharmaceuticals, Inc.
FDA inspection history in Rancho Cucamonga, California, 2017 to 2024
- 2
- Form 483s
Every document, by year
- Form 483
2017: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017One Form 483, at Rancho Cucamonga, California.
- 2017The longest 483 on file: 20 observations over 28 pages at Rancho Cucamonga, California.
- 2024One Form 483, at Rancho Cucamonga, California.
Cited most
Across all Amphastar Pharmaceuticals observations on file
- 21 CFR 820.30Design controls6
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.22Responsibilities of quality control unit3
- 21 CFR 211.165Testing and release for distribution2
- 21 CFR 211.192Production record review2
The complete Amphastar Pharmaceuticals 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
Rancho Cucamonga, California
Two Form 483s · 2017 to 2024 · 26 observations
Latest: Form 483, Mar 1, 2024 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-03-01 | 483 Form 483 | Rancho Cucamonga, California | 6 | $99 |
| 2017-03-31 | 483 Form 483 | Rancho Cucamonga, California | 20 | $99 |
Investigators on these documents
Walden H. Lee (2)Amir Alavi (1)Carrie A. Hughes (1)Crystal Monroy (1)Homero W. Aguilar (1)Jeffrey P. Raimondi (1)Jennifer M. Gogley (1)Lillian S. Wu (1)Marcus F. Yambot (1)Sonya L. Karsik (1)Amanda L. Fyles (1)Xiaohui Shen (1)
FEI number 3002936358 · most recent document Mar 1, 2024
About Amphastar Pharmaceuticals, Inc.
How many FDA Form 483s has Amphastar Pharmaceuticals, Inc. received?
FDA Intel has 2 Form 483s on file for Amphastar Pharmaceuticals, Inc.; the most recent is dated Mar 1, 2024.
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 1, 2024, 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), 6 times; 21 CFR 211.113 (Control of microbiological contamination), 3 times; 21 CFR 211.22 (Responsibilities of quality control unit), 3 times.