FDA Inspection
Navajo Manufacturing CompanyNavajo Manufacturing Company – FDA Inspection, Dec 29, 2009
Record Details
This FDA Inspection record concerns Navajo Manufacturing Company, with an inspection on December 29, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Navajo Manufacturing Company
- Inspection Date
- December 29, 2009
- Product Type
- Drugs
View Company Profile
ID · 8e45a057-1441-4c0d-a239-8859d0fd6e67
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 639019
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.134(b)Representative samples after completion
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.150(b)Distribution Recall System
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.198(a)Complaints reviewed by Quality Control Unit
- 21 CFR 211.142(a)Quarantine - written procedures
- 21 CFR 211.100(b)SOPs not followed / documented
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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 |
| January 28, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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 708089 - 2011-01-28
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