FDA Inspection
Cascadia Manufacturing IncCascadia Manufacturing Inc – FDA Inspection, Mar 1, 2016
Record Details
This FDA Inspection record concerns Cascadia Manufacturing Inc, with an inspection on March 1, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Cascadia Manufacturing Inc
- Inspection Date
- March 1, 2016
- Product Type
- Drugs
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ID · e300c499-b6cd-4d60-871c-af4e315e4fc3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 985991
- FDA center
- Human Drugs
- Project area
- Unapproved and Misbranded Drugs
FDA Citations
20- 21 CFR 211.170(a)Active ingredient retained sample kept
- 21 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.84(d)(6)Microbiological Contamination Exam
- 21 CFR 211.80(d)Status of Each Lot Identified
- 21 CFR 211.46(b)Equipment for Environmental Control
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.130Procedures are written, and followed
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Other FDA inspections of Cascadia Manufacturing Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| August 14, 2009 | OAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
Other documents for Cascadia Manufacturing Inc
- FDA Inspection 787973 - 2012-07-12
- FDA Inspection 743164 - 2011-09-07
- FDA Inspection 696483 - 2010-11-16
- FDA Inspection 609014 - 2009-08-14
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