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FDA Inspection
•Accupac, Inc.•December 19, 2017

Accupac, Inc. – FDA Inspection, Dec 19, 2017

Record Details

This FDA Inspection record concerns Accupac, Inc., with an inspection on December 19, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Accupac, Inc.
Inspection Date
December 19, 2017
Product Type
Drugs
Office
Center for Drug Evaluation and Research
People
  • David A. Oluwo (FDA Associated Person)
  • James M. Mason (Issuing Officer)
View Company Profile

ID · b5595a66-52d8-4989-a6b3-280e30bf5ffe

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1035664
FDA center
Human Drugs
Project area
Drug Quality Assurance
Outcome
Form 483 issued

FDA Citations

2
  1. 21 CFR 211.58Buildings not maintained in good state of repair
  2. 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Accupac, Inc.

2
DateClassificationOfficeProject area
March 31, 2016NAICenter for Food Safety and Applied NutritionColors and Cosmetics Technology
April 14, 2011NAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for Accupac, Inc.
  • FDA Inspection 962143 - 2016-03-31
  • FDA Inspection 719132 - 2011-04-14

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