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FDA Inspection
•H & P Industries, Inc.•February 5, 2009

H & P Industries, Inc. – FDA Inspection, Feb 5, 2009

Record Details

This FDA Inspection record concerns H & P Industries, Inc., with an inspection on February 5, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
H & P Industries, Inc.
Inspection Date
February 5, 2009
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · 56354f98-124e-493d-9401-0c559c20de25

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number
557911
FDA center
Human Drugs
Project area
Drug Quality Assurance

FDA Citations

7
  1. 21 CFR 211.58Buildings not maintained in good state of repair
  2. 21 CFR 211.165(f)Failing drug products not rejected
  3. 21 CFR 211.192Extent of discrepancy, failure investigations
  4. 21 CFR 211.115(a)Reprocessing procedures not written or followed
  5. 21 CFR 211.22(d)Procedures not in writing, fully followed
  6. 21 CFR 211.166(a)Written program not followed
  7. 21 CFR 211.180(e)(2)Items to cover on annual reviews

Full citation text and observation details available on the Dashboard.

Other FDA inspections of H & P Industries, Inc.

8
DateClassificationOfficeProject area
March 28, 2011OAICenter for Drug Evaluation and ResearchDrug Quality Assurance
January 7, 2011OAICenter for Devices and Radiological HealthCompliance: Devices
January 4, 2011NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
November 10, 2010NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
May 18, 2010OAICenter for Devices and Radiological HealthCompliance: Devices
View all 8 other inspections on the company page
Other documents for H & P Industries, Inc.
  • FDA Inspection 716726 - 2011-03-28
  • FDA Inspection 700534 - 2011-01-07
  • FDA Inspection 704694 - 2011-01-04
  • FDA Inspection 697221 - 2010-11-10
  • FDA Inspection 662690 - 2010-05-18

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