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FDA Inspection
•Hawknad Manufacturing Industries, Inc.•August 2, 2013

FDA Inspection 839653 - Hawknad Manufacturing Industries, Inc. - August 02, 2013

Record Details

This FDA Inspection record concerns Hawknad Manufacturing Industries, Inc., with an inspection on August 2, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Hawknad Manufacturing Industries, Inc.
Inspection Date
August 2, 2013
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · 2930db73-b880-46d7-93a3-ff0e66e67231

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
839653
FDA center
Human Drugs
Project area
Drug Quality Assurance

FDA Citations

5
  1. 21 CFR 211.68(a)Calibration/Inspection/Checking not done
  2. 21 CFR 211.84(b)Representative Samples Criteria
  3. 21 CFR 211.22(d)Procedures not in writing, fully followed
  4. 21 CFR 211.80(a)Procedures To Be in Writing
  5. 21 CFR 211.67(b)Written procedures fail to include

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Hawknad Manufacturing Industries, Inc.

4
DateClassificationOfficeProject area
April 28, 2016VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
April 23, 2015VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
August 15, 2012VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
April 18, 2011OAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for Hawknad Manufacturing Industries, Inc.
  • FDA Inspection 980679 - 2016-04-28
  • FDA Inspection 921846 - 2015-04-23
  • FDA Inspection 793901 - 2012-08-15
  • FDA Inspection 718178 - 2011-04-18

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