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FDA Inspection
•Troy Manufacturing, Inc.•June 1, 2016

Troy Manufacturing, Inc. – FDA Inspection, Jun 1, 2016

Record Details

This FDA Inspection record concerns Troy Manufacturing, Inc., with an inspection on June 1, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Troy Manufacturing, Inc.
Inspection Date
June 1, 2016
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · 55567dae-e8c3-4beb-8413-4c21f710f872

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
976402
FDA center
Human Drugs
Project area
Drug Quality Assurance

FDA Citations

5
  1. 21 CFR 211.160(b)Scientifically sound laboratory controls
  2. 21 CFR 211.194(a)(5)Testing Calculations
  3. 21 CFR 211.192Investigations of discrepancies, failures
  4. 21 CFR 211.67(b)Written procedures not established/followed
  5. 21 CFR 211.110(a)Written in-process control procedures

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Troy Manufacturing, Inc.

4
DateClassificationOfficeProject area
June 12, 2025Not classifiedPhiladelphia District Office
February 7, 2019VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
February 12, 2013VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
August 30, 2010NAICenter for Veterinary MedicineMonitoring of Marketed Animal Drugs, Feed, and Devices
Other documents for Troy Manufacturing, Inc.
  • FDA Inspection 1275066 - 2025-06-12
  • FDA Inspection 1079580 - 2019-02-07
  • FDA Inspection 819009 - 2013-02-12
  • FDA Inspection 678212 - 2010-08-30

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