Company
United StatesPublic company, NASDAQ: AMPHAmphastar Pharmaceuticals, Inc. (NASDAQ: AMPH), Rancho Cucamonga, CA – FDA Inspections
Inspection records and compliance data for Amphastar Pharmaceuticals, Inc. in Rancho Cucamonga, California. 15 FDA inspections on record (1 OAI), 3 Form 483s, last inspected November 07, 2025. Publicly traded as NASDAQ: AMPH.
Company Profile
This profile covers Amphastar Pharmaceuticals, Inc. based in Rancho Cucamonga, California, United States.
FDA Inspection History
- FDA inspections
- 15
- OAI
- 1
- VAI
- 5
- NAI
- 8
- Unclassified
- 1
- Form 483s
- 3
- Warning letters
- 0
First inspected August 19, 2009. Last inspected November 7, 2025.
Most cited issue areas
- Prepared for each batch, include complete information2 inspections
- Procedures for sterile drug products2 inspections
- SOPs not followed / documented2 inspections
FDA inspections (15)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 7, 2025 | Not classified | Human Drugs | 1290538 |
| April 3, 2025 | NAI | Human Drugs · Bioresearch Monitoring | 1266798 |
| March 1, 2024 | VAI | Human Drugs · Drug Quality Assurance | 1229403 |
| June 22, 2021 | NAI | Human Drugs · Drug Quality Assurance | 1144508 |
| November 22, 2019 | NAI | Human Drugs · Bioresearch Monitoring | 1113865 |
| November 21, 2019 | NAI | Human Drugs · Bioresearch Monitoring | 1115634 |
| July 25, 2019 | NAI | Human Drugs · Bioresearch Monitoring | 1100047 |
| February 12, 2019 | VAI | Human Drugs · Generic Drug Evaluation | 1079028 |
| March 31, 2017 | OAI | Human Drugs, Medical Devices & Rad Health · Compliance: Devices | 1009137 |
| August 8, 2014 | NAI | Human Drugs · Bioresearch Monitoring | 890492 |
| March 3, 2014 | NAI | Human Drugs · Bioresearch Monitoring | 871689 |
| February 6, 2013 | VAI | Human Drugs · Drug Quality Assurance | 819296 |
| June 28, 2012 | VAI | Human Drugs · Drug Quality Assurance | 787992 |
| May 6, 2011 | VAI | Human Drugs · Drug Quality Assurance | 724317 |
| August 19, 2009 | NAI | Human Drugs · Bioresearch Monitoring | 609825 |
FDA documents
Other FDA documents (2)
People (5)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Amphastar Pharmaceuticals, Inc.
Stock ticker
AMPH
Exchange
NASDAQ
Share price
$28.87
Market cap
$1.2B
Price as of
November 13, 2026
FEI Number
3002936358
Address
11570 6th St, Rancho Cucamonga, California 91730, United States
Country
United States
ID: e90eb882-5679-4c85-bbc8-f69ca69cc537