FDA Inspection
Navajo Manufacturing CompanyNavajo Manufacturing Company – FDA Inspection, Jul 9, 2013
Record Details
This FDA Inspection record concerns Navajo Manufacturing Company, with an inspection on July 9, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Navajo Manufacturing Company
- Inspection Date
- July 9, 2013
- Product Type
- Drugs
View Company Profile
ID · 1df6f297-f18c-47a3-a8ce-96547877b7fa
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 840309
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.82(a)Examination on receipt, before acceptance
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.115(b)Reprocessing/quality control unit
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.100(b)SOPs not followed / documented
Full citation text and observation details available on the Dashboard.
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 |
| 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 |
| 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 786600 - 2012-06-11
- FDA Inspection 708089 - 2011-01-28
- FDA Inspection 650990 - 2010-03-11
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