FDA Inspection
Capco Custom Packaging IncCapco Custom Packaging Inc – FDA Inspection, Feb 10, 2011
Record Details
This FDA Inspection record concerns Capco Custom Packaging Inc, with an inspection on February 10, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Capco Custom Packaging Inc
- Inspection Date
- February 10, 2011
- Product Type
- Drugs
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ID · da0c071d-5aaf-4482-a681-41eba6c0cabf
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 709983
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.84(d)(2)Testing Each Component for Conformity with Specs
- 21 CFR 211.110(c)In-process materials characteristics testing
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.84(d)(1)Identity Testing of Each Component
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
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Other FDA inspections of Capco Custom Packaging Inc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| September 11, 2018 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| September 23, 2015 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| August 23, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 18, 2012 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 1, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Capco Custom Packaging Inc
- FDA Inspection 1070520 - 2018-09-11
- FDA Inspection 944218 - 2015-09-23
- FDA Inspection 846382 - 2013-08-23
- FDA Inspection 782537 - 2012-05-18
- FDA Inspection 641512 - 2010-02-01
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