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FDA Inspection
•Taro Pharmaceuticals Inc.•May 3, 2019

Taro Pharmaceuticals Inc. – FDA Inspection, May 3, 2019

Record Details

This FDA Inspection record concerns Taro Pharmaceuticals Inc., with an inspection on May 3, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Taro Pharmaceuticals Inc.
Inspection Date
May 3, 2019
Product Type
Drugs
Office
Center for Drug Evaluation and Research
Person
  • Carrie A. Hughes (Issuing Officer)
View Company Profile

ID · 6c8456ba-f9bc-45c1-aab9-d88bf456c31a

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1088553
FDA center
Human Drugs
Project area
Drug Quality Assurance
Outcome
Form 483 issued

FDA Citations

3
  1. 21 CFR 211.194(a)(1)Description and Identification of Samples
  2. 21 CFR 211.100(b)SOPs not followed / documented
  3. 21 CFR 211.192No written record of investigation

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Taro Pharmaceuticals Inc.

7
DateClassificationOfficeProject area
March 27, 2026NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
September 20, 2024Not classifiedOffice of Inspections and Investigations
September 16, 2022VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
January 20, 2017VAIOffice of Inspections and InvestigationsGeneric Drug Evaluation
July 29, 2016NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
View all 7 other inspections on the company page
Other documents for Taro Pharmaceuticals Inc.
  • FDA Inspection 1312804 - 2026-03-27
  • FDA Inspection 1257703 - 2024-09-20
  • FDA Inspection 1180887 - 2022-09-16
  • FDA Inspection 1001628 - 2017-01-20
  • FDA Inspection 984831 - 2016-07-29

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