FDA Inspection
Navajo Manufacturing CompanyNavajo Manufacturing Company – FDA Inspection, Jan 28, 2011
Record Details
This FDA Inspection record concerns Navajo Manufacturing Company, with an inspection on January 28, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Navajo Manufacturing Company
- Inspection Date
- January 28, 2011
- Product Type
- Drugs
View Company Profile
ID · e16069a7-d9e3-4386-9356-ef144cebb555
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 708089
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.68(b)input/output verification
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.186(a)Written procedures followed
- 21 CFR 211.150(b)Distribution Recall System
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.180(e)(1)Review of representative number of batches
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Other FDA inspections of Navajo Manufacturing Company
6| Date | Classification | Office | Project area |
|---|---|---|---|
| December 5, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 22, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 9, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 11, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 11, 2010 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Navajo Manufacturing Company
- FDA Inspection 905874 - 2014-12-05
- FDA Inspection 899142 - 2014-08-22
- FDA Inspection 840309 - 2013-07-09
- FDA Inspection 786600 - 2012-06-11
- FDA Inspection 650990 - 2010-03-11
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