FDA Inspection
Navajo Manufacturing CompanyNavajo Manufacturing Company – FDA Inspection, Aug 22, 2014
Record Details
This FDA Inspection record concerns Navajo Manufacturing Company, with an inspection on August 22, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Navajo Manufacturing Company
- Inspection Date
- August 22, 2014
- Product Type
- Drugs
View Company Profile
ID · 8ae59a6f-c5f0-4ef2-85e4-bbcf34b9ad5d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 899142
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.182Specific information required in individual logs
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 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
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 |
| 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 |
| 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 840309 - 2013-07-09
- FDA Inspection 786600 - 2012-06-11
- FDA Inspection 708089 - 2011-01-28
- FDA Inspection 650990 - 2010-03-11
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.