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FDA Inspection
•HRC Laboratories Inc.•June 13, 2011

HRC Laboratories Inc. – FDA Inspection, Jun 13, 2011

Record Details

This FDA Inspection record concerns HRC Laboratories Inc., with an inspection on June 13, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
HRC Laboratories Inc.
Inspection Date
June 13, 2011
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · b3f8766c-e226-4105-8d19-a605f1d8db29

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
729195
FDA center
Human Drugs
Project area
Drug Quality Assurance

FDA Citations

4
  1. 21 CFR 211.170(a)Active ingredient retained sample kept
  2. 21 CFR 211.188Prepared for each batch, include complete information
  3. 21 CFR 211.84(d)(2)Reports of Analysis (Components)
  4. 21 CFR 211.166(c)(1)Homeopathic drugs, assessment of stability

Full citation text and observation details available on the Dashboard.

Other FDA inspections of HRC Laboratories Inc.

3
DateClassificationOfficeProject area
March 3, 2017NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
June 1, 2012NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
January 23, 2009VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for HRC Laboratories Inc.
  • FDA Inspection 1025426 - 2017-03-03
  • FDA Inspection 788988 - 2012-06-01
  • FDA Inspection 558241 - 2009-01-23

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