Amphastar Pharmaceuticals, Inc.
Form 483 issued March 31, 2017 · Rancho Cucamonga, California
- Inspection
- Mar 13 – Mar 31, 2017
- Investigators
- Amanda L. Fyles· Amir Alavi· Carrie A. Hughes
- Observations
- 20
- Pages
- 28
- FEI number
- 3002936358
In short: On March 31, 2017, FDA issued a Form 483 with 20 observations to Amphastar Pharmaceuticals, Inc. in Rancho Cucamonga, California (FEI 3002936358) after an inspection that ran Mar 13 – Mar 31, 2017. The investigators were Amanda L. Fyles, Amir Alavi, Carrie A. Hughes, Jeffrey P. Raimondi, Jennifer M. Gogley, Marcus F. Yambot, Sonya L. Karsik, Walden H. Lee and Xiaohui Shen. Most observations concern design controls and production; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
Observations span 4 systems, led by design controls.
Most cited: 21 CFR 820.30 (5×) · 211.113 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Design plans that describe or reference the design and development activities and define responsibility for implementation…
- 02
Procedures for design output have…
- 03
Risk analysis is inadequate…
- 04
Design input requirements were…
This inspection in context
Amanda L. Fyles
5 documents · 2017–2019
Cites 211.165 (testing and release for distribution) 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 820.30
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Amphastar Pharmaceuticals, Inc.?
FDA listed 20 observations on this Form 483, mostly about design controls, production and quality system. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Amphastar Pharmaceuticals, Inc.?
Amanda L. Fyles, Amir Alavi, Carrie A. Hughes, Jeffrey P. Raimondi, Jennifer M. Gogley, Marcus F. Yambot, Sonya L. Karsik, Walden H. Lee and Xiaohui Shen are named on this Form 483, for the inspection of Mar 13 – Mar 31, 2017. Each investigator has a profile showing what they cite most.
When was Amphastar Pharmaceuticals, Inc. inspected by FDA?
The inspection ran Mar 13 – Mar 31, 2017, and the Form 483 is dated March 31, 2017.
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.