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FDA Inspection
•Amerisource Health Services LLC•July 16, 2010

Amerisource Health Services LLC – FDA Inspection, Jul 16, 2010

Record Details

This FDA Inspection record concerns Amerisource Health Services LLC, with an inspection on July 16, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Amerisource Health Services LLC
Inspection Date
July 16, 2010
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · 0a29171d-eede-4145-b044-cf4c153ebb31

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
682115
FDA center
Human Drugs
Project area
Drug Quality Assurance

FDA Citations

5
  1. 21 CFR 211.122(b)Labeling and packaging improperly approved/released
  2. 21 CFR 211.100(a)Absence of Written Procedures
  3. 21 CFR 211.192Investigations of discrepancies, failures
  4. 21 CFR 211.67(b)Written procedures fail to include
  5. 21 CFR 211.100(b)SOPs not followed / documented

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Amerisource Health Services LLC

7
DateClassificationOfficeProject area
June 15, 2026Not classifiedCincinnati District Office
May 27, 2022NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
August 16, 2017NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
June 15, 2017VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
July 30, 2015NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
View all 7 other inspections on the company page
Other documents for Amerisource Health Services LLC
  • FDA Inspection 1303774 - 2026-06-15
  • FDA Inspection 1172267 - 2022-05-27
  • FDA Inspection 1023170 - 2017-08-16
  • FDA Inspection 1015801 - 2017-06-15
  • FDA Inspection 936288 - 2015-07-30

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