FDA Inspection
Contract Supplement Packaging, LLCContract Supplement Packaging, LLC – FDA Inspection, Apr 23, 2009
Record Details
This FDA Inspection record concerns Contract Supplement Packaging, LLC, with an inspection on April 23, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- April 23, 2009
- Product Type
- Drugs
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ID · b828bbf8-eed5-4a10-9a04-754b9d90eb35
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 582411
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.84(d)(3)Testing Containers & Closures Conformity with Specs
- 21 CFR 211.84(a)Components withheld from use pending release
- 21 CFR 211.82(b)Quarantine Storage of Components
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.46(c)Air filtration system lacking in production area
- 21 CFR 211.80(a)Procedures To Be in Writing
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of Contract Supplement Packaging, LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| June 22, 2023 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| June 16, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 10, 2014 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| February 22, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Contract Supplement Packaging, LLC
- FDA Inspection 1209600 - 2023-06-22
- FDA Inspection 1014737 - 2017-06-16
- FDA Inspection 899812 - 2014-10-10
- FDA Inspection 769047 - 2012-02-22
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