FDA Inspection
GenPak Solutions LLCGenPak Solutions LLC – FDA Inspection, Jun 15, 2017
Record Details
This FDA Inspection record concerns GenPak Solutions LLC, with an inspection on June 15, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 554bfadb-44f1-48bd-bd9d-afd781da3cda
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1014779
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.166(a)Lack of written stability program
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Other FDA inspections of GenPak Solutions LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 12, 2015 | OAI | 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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