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Amphastar Pharmaceuticals, Inc. FDA Inspection Record

FEI 3002936358 · Inspections, Form 483s, warning letters and import refusals

Amphastar Pharmaceuticals, Inc. is an FDA-registered facility (FEI 3002936358) located in Rancho Cucamonga, CA, US. Registered operations: ANALYSIS; DISTRIBUTE; LABEL; MANUFACTURE; PACK. RegDataLab tracks 14 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Nov 7, 2025: Voluntary Action Indicated (VAI)
Inspections on record
14 (7 VAI, 7 NAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Recalls as the recalling firm
1, latest Aug 15, 2017
Import refusals
2

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Showing the 10 most recent of 14 inspections. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Nov 7, 2025Voluntary Action Indicated (VAI)No citations listed
Apr 3, 2025No Action Indicated (NAI)No citations listed
Mar 1, 2024Voluntary Action Indicated (VAI)No citations listed
Jun 22, 2021No Action Indicated (NAI)No citations listed
Nov 22, 2019No Action Indicated (NAI)No citations listed
Nov 21, 2019No Action Indicated (NAI)No citations listed
Jul 25, 2019No Action Indicated (NAI)No citations listed
Mar 31, 2017Voluntary Action Indicated (VAI)No citations listed
Aug 8, 2014Voluntary Action Indicated (VAI)No citations listed
Mar 3, 2014No Action Indicated (NAI)No citations listed

Recalls

Newest first. Recalls FDA's Enforcement Report lists with this FEI as the recalling firm. The recalling firm is not always the site that made the product. Search FDA's Enforcement Report by recall number.

DateClassRecallProduct and reason
Aug 15, 2017Class IID-1124-2017Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL single-dose vials, Rx…
Crystallization: Particulate matter (Ketorolac Calcium Salt) was observed from several lots of retained samples.

FDA record score

12 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.

Counted on Nov 14, 2026, method version 1. It counts records and does not judge the site: a low number does not establish that a site is safe, and sites that FDA inspects more often can collect more points. How this is counted.

8 records behind this number
RecordDatePoints x age weightAdds
Inspection classified VAINov 7, 20256 x 16
Inspection classified VAIMar 1, 20246 x 0.63.6
Inspection classified VAIMar 31, 20176 x 0.251.5
Class II recall D-1124-2017, this FEI as the recalling firmAug 15, 20174 x 0.251
Inspection classified VAIAug 8, 201410 years or older, so it adds no points0
Inspection classified VAIFeb 6, 201310 years or older, so it adds no points0
Inspection classified VAIJun 28, 201210 years or older, so it adds no points0
Inspection classified VAIAug 19, 200910 years or older, so it adds no points0

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 14, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 14, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 14, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 2, 2026Newest record Oct 22, 2026Current

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Facility details

Company
Amphastar Pharmaceuticals, Inc.
Location
Rancho Cucamonga, CA (US)
Registration Expires
Dec 31, 2026
Operations
ANALYSIS; DISTRIBUTE; LABEL; MANUFACTURE; PACK
Source
decrs

Import refusals

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.