FDA Inspection
Cascadia Manufacturing IncCascadia Manufacturing Inc – FDA Inspection, Aug 14, 2009
Record Details
This FDA Inspection record concerns Cascadia Manufacturing Inc, with an inspection on August 14, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Cascadia Manufacturing Inc
- Inspection Date
- August 14, 2009
- Product Type
- Drugs
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ID · a703aa1c-0545-47ce-98fd-2bed819cf9ae
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 609014
- FDA center
- Human Drugs
- Project area
- Unapproved and Misbranded Drugs
FDA Citations
18- 21 CFR 211.165(d)Acceptance criteria for sampling & testing
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.84(d)(6)Microbiological Contamination Exam
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
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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 |
| November 16, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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 696483 - 2010-11-16
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