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FDA Inspection
•Aidapak Services, LLC•July 31, 2013

Aidapak Services, LLC – FDA Inspection, Jul 31, 2013

Record Details

This FDA Inspection record concerns Aidapak Services, LLC, with an inspection on July 31, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Aidapak Services, LLC
Inspection Date
July 31, 2013
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · 4cda8b77-937d-48fd-85c1-9971278bd257

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
844026
FDA center
Human Drugs
Project area
Drug Quality Assurance

FDA Citations

9
  1. 21 CFR 211.58Buildings not maintained in good state of repair
  2. 21 CFR 211.130(d)Examination of packaging and labeling
  3. 21 CFR 211.130(e)Packaging line inspection before use
  4. 21 CFR 211.130(e)Packaging line inspection after use
  5. 21 CFR 211.130Procedures are written, and followed
  6. 21 CFR 211.170(b)Reserve samples identified, representative, stored
  7. 21 CFR 211.125(a)Strict control not exercised over labeling issued
  8. 21 CFR 211.67(b)Written procedures not established/followed
  9. 21 CFR 211.192Written record of investigation incomplete

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Aidapak Services, LLC

2
DateClassificationOfficeProject area
June 19, 2012VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
January 6, 2011VAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
Other documents for Aidapak Services, LLC
  • FDA Inspection 792749 - 2012-06-19
  • FDA Inspection 705885 - 2011-01-06

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