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FDA Inspection
•Respa Pharmaceuticals Inc.•October 4, 2012

Respa Pharmaceuticals Inc. – FDA Inspection, Oct 4, 2012

Record Details

This FDA Inspection record concerns Respa Pharmaceuticals Inc., with an inspection on October 4, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Respa Pharmaceuticals Inc.
Inspection Date
October 4, 2012
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · 72083ff8-c4da-42a5-a9fc-9ac800c23b1c

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
801001
FDA center
Human Drugs
Project area
Drug Quality Assurance

FDA Citations

3
  1. Drug Field Exam
  2. 21 CFR 211.198(a)Complaint Handling Procedure
  3. 21 CFR 211.22(d)Procedures not in writing, fully followed

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Respa Pharmaceuticals Inc.

1
DateClassificationOfficeProject area
August 4, 2011VAICenter for Drug Evaluation and ResearchPostmarket Surv. and Epidemiology
Other documents for Respa Pharmaceuticals Inc.
  • FDA Inspection 738390 - 2011-08-04

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