FDA Inspection
Contract Supplement Packaging, LLCContract Supplement Packaging, LLC – FDA Inspection, Jun 16, 2017
Record Details
This FDA Inspection record concerns Contract Supplement Packaging, LLC, with an inspection on June 16, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · c538d2fd-4412-48fd-b845-92e1db803966
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1014737
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.188(b)(5)In-process and laboratory control results
- 21 CFR 211.125(c)Label reconciliation discrepancies evaluation/investigation
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.110(a)Written in-process control procedures
- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.192No written record of investigation
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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 |
| 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 |
| April 23, 2009 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Contract Supplement Packaging, LLC
- FDA Inspection 1209600 - 2023-06-22
- FDA Inspection 899812 - 2014-10-10
- FDA Inspection 769047 - 2012-02-22
- FDA Inspection 582411 - 2009-04-23
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