FDA Inspection
Cascadia Manufacturing IncCascadia Manufacturing Inc – FDA Inspection, Nov 16, 2010
Record Details
This FDA Inspection record concerns Cascadia Manufacturing Inc, with an inspection on November 16, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Cascadia Manufacturing Inc
- Inspection Date
- November 16, 2010
- Product Type
- Drugs
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ID · 96bb8cc2-5807-4932-b3c7-e07bc6db70c0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 696483
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
24- 21 CFR 211.165(d)Acceptance criteria for sampling & testing
- 21 CFR 211.103Actual vs. theoretical yields not determined
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.84(d)(6)Objectionable microbiological contamination
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.65(a)Equipment construction - reactive surfaces
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.130(d)Examination of packaging and labeling
- 21 CFR 211.192Extent of discrepancy, failure investigations
Showing 10 of 24 citations.
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Other FDA inspections of Cascadia Manufacturing Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 1, 2016 | VAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
| July 12, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 7, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 14, 2009 | OAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
Other documents for Cascadia Manufacturing Inc
- FDA Inspection 985991 - 2016-03-01
- FDA Inspection 787973 - 2012-07-12
- FDA Inspection 743164 - 2011-09-07
- FDA Inspection 609014 - 2009-08-14
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