FDA Inspection
Silgan Unicep Packaging LLCSilgan Unicep Packaging LLC – FDA Inspection, May 25, 2018
Record Details
This FDA Inspection record concerns Silgan Unicep Packaging LLC, with an inspection on May 25, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · a6f49d8a-6289-4e1c-b6c3-6376a27e9d33
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1053505
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.170(a)Active ingredient retained sample kept
- 21 CFR 211.113(a)Procedures for non-sterile drug products
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Other FDA inspections of Silgan Unicep Packaging LLC
7| Date | Classification | Office | Project area |
|---|---|---|---|
| December 1, 2022 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 30, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 4, 2016 | VAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| February 28, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 7, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Silgan Unicep Packaging LLC
- FDA Inspection 1193902 - 2022-12-01
- FDA Inspection 1014496 - 2017-03-30
- FDA Inspection 991913 - 2016-11-04
- FDA Inspection 871964 - 2014-02-28
- FDA Inspection 845770 - 2013-08-07
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