FDA Inspection
Amphastar Pharmaceuticals, Inc.Amphastar Pharmaceuticals, Inc. – FDA Inspection, Mar 31, 2017
Record Details
This FDA Inspection record concerns Amphastar Pharmaceuticals, Inc., with an inspection on March 31, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- People
- Amanda L. Fyles (Company Rep)
- Amir Alavi (Company Rep)
- Carrie A. Hughes (Issuing Officer)
- Jeffrey P. Raimondi (Investigator)
- Jennifer M. Gogley (FDA Associated Person)
- Marcus F. Yambot (FDA Associated Person)
- Sonya L. Karsik (FDA Associated Person)
- Walden H. Lee (FDA Associated Person)
- Xiaohui Shen (FDA Associated Person)
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ID · 197f0b72-c7e5-4db2-9ce9-905c1852636e
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1009137
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
20- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.180(b)Record maintenance 1 year (except exempt OTC)
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.192Written record of investigation incomplete
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
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Other FDA inspections of Amphastar Pharmaceuticals, Inc.
14| Date | Classification | Office | Project area |
|---|---|---|---|
| November 7, 2025 | Not classified | Los Angeles District Office | |
| April 3, 2025 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| March 1, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 22, 2021 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 22, 2019 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Amphastar Pharmaceuticals, Inc.
- FDA Inspection 1290538 - 2025-11-07
- FDA Inspection 1266798 - 2025-04-03
- FDA Inspection 1229403 - 2024-03-01
- FDA Inspection 1144508 - 2021-06-22
- FDA Inspection 1113865 - 2019-11-22
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