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FDA Inspection
•Grandpa Brands Company•May 15, 2012

Grandpa Brands Company – FDA Inspection, May 15, 2012

Record Details

This FDA Inspection record concerns Grandpa Brands Company, with an inspection on May 15, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Grandpa Brands Company
Inspection Date
May 15, 2012
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · 04652e37-e029-4a39-b1f4-2510164132aa

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
779900
FDA center
Human Drugs
Project area
Drug Quality Assurance

FDA Citations

17
  1. 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
  2. 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
  3. 21 CFR 211.110(a)Control procedures to monitor and validate performance
  4. 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
  5. 21 CFR 211.196Distribution Record Requirements
  6. 21 CFR 211.165(f)Failing drug products not rejected
  7. 21 CFR 211.25(a)Training , Education , Experience overall
  8. 21 CFR 211.63Equipment Design, Size and Location
  9. 21 CFR 211.198(a)Complaint Handling Procedure
  10. 21 CFR 211.34Consultant Records

Showing 10 of 17 citations.

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Grandpa Brands Company

1
DateClassificationOfficeProject area
November 25, 2009VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for Grandpa Brands Company
  • FDA Inspection 633801 - 2009-11-25

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