FDA Inspection
GenPak Solutions LLCGenPak Solutions LLC – FDA Inspection, Aug 12, 2015
Record Details
This FDA Inspection record concerns GenPak Solutions LLC, with an inspection on August 12, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- GenPak Solutions LLC
- Inspection Date
- August 12, 2015
- Product Type
- Drugs
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ID · d6d5144b-c540-4435-bf4e-0f39cd2d721c
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 939392
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of GenPak Solutions LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 15, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 10, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 23, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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