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•United States

Bachem Americas, Inc., Vista, CA – FDA Inspections

Inspection records and compliance data for Bachem Americas, Inc. in Vista, California. 6 FDA inspections on record, 3 Form 483s, last inspected May 20, 2026.

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Company Profile

This profile covers Bachem Americas, Inc. based in Vista, California, United States.

FDA Inspection History

FDA inspections
6
OAI
0
VAI
3
NAI
2
Unclassified
1
Form 483s
3
Warning letters
0

First inspected May 6, 2010. Last inspected May 20, 2026.

Most cited issue areas

  • Computer control of master formula records1 inspection
  • Plumbing System Defects1 inspection

FDA inspections (6)

DateResultFDA center(s)Insp. #
May 20, 2026Not classifiedHuman Drugs1318910
March 27, 2023VAIHuman Drugs · Drug Quality Assurance1202822
February 5, 2019NAIHuman Drugs · Drug Quality Assurance1081460
February 10, 2017VAIHuman Drugs · New Drug Evaluation1003665
June 2, 2011VAIAnimal Drugs & Feeds, Human Drugs · Monitoring of Marketed Animal Drugs, Feed, and Devices727544
May 6, 2010NAIAnimal Drugs & Feeds, Human Drugs · Drug Quality Assurance660975
FDA documents

Form 483s (3)

  • Form 483s · May 20, 2026
  • Form 483s · March 20, 2023
  • Form 483s · February 10, 2017

EIRs (2)

  • EIRs · March 27, 2023
  • EIRs · February 10, 2017
People (4)
Walden H. Lee
Person
Santos E. Camara
Person
Brian Gregg
Person
Cecilia H. Kieu
Person
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Company Information

Name

Bachem Americas, Inc.

FEI Number

3000718309

Address

1271 Avenida Chelsea, Vista, California 92081, United States

Country

United States

ID: f0157d2d-6b0c-4b13-afd4-551c2ab94aad

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