Amphastar Pharmaceuticals, Inc.
Form 483 issued March 1, 2024 · Rancho Cucamonga, California
- Inspection
- Feb 20 – Mar 1, 2024
- Investigators
- Crystal Monroy· Homero W. Aguilar· Lillian S. Wu
- Observations
- 6
- Pages
- 6
- FEI number
- 3002936358
In short: On March 1, 2024, FDA issued a Form 483 with 6 observations to Amphastar Pharmaceuticals, Inc. in Rancho Cucamonga, California (FEI 3002936358) after an inspection that ran Feb 20 – Mar 1, 2024. The investigators were Crystal Monroy, Homero W. Aguilar, Lillian S. Wu and Walden H. Lee. Most observations concern laboratory controls and quality system.
At a glance
Laboratory controls and quality system account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Computer systems are not maintained…
- 02
The accuracy of test methods…
- 03
Laboratory records do not include complete data derived from all tests, examination and assay necessary to…
- 04
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Crystal Monroy
15 documents · 2014–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.
The firmAmphastar Pharmaceuticals, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Amphastar Pharmaceuticals, Inc.?
FDA listed 6 observations on this Form 483, mostly about laboratory controls, quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Amphastar Pharmaceuticals, Inc.?
Crystal Monroy, Homero W. Aguilar, Lillian S. Wu and Walden H. Lee are named on this Form 483, for the inspection of Feb 20 – Mar 1, 2024. Each investigator has a profile showing what they cite most.
When was Amphastar Pharmaceuticals, Inc. inspected by FDA?
The inspection ran Feb 20 – Mar 1, 2024, and the Form 483 is dated March 1, 2024.
How do I get the full Form 483 for Amphastar Pharmaceuticals, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.