FDA Inspection
Silgan Unicep Packaging LLCSilgan Unicep Packaging LLC – FDA Inspection, Mar 16, 2010
Record Details
This FDA Inspection record concerns Silgan Unicep Packaging LLC, with an inspection on March 16, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Silgan Unicep Packaging LLC
- Inspection Date
- March 16, 2010
- Product Type
- Drugs
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ID · ca24fcba-139b-418a-91c9-6211ada05c1a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 656377
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
18- 21 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)(4)Data secured in course of each test
- 21 CFR 211.194(a)(5)Calculations performed are in the records
- 21 CFR 211.194(a)(2)Statement of methods and data
- 21 CFR 211.194(a)(3)Weight or measure of sample
- 21 CFR 211.194(a)Complete test data included in records
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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 |
| May 25, 2018 | VAI | 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 |
Other documents for Silgan Unicep Packaging LLC
- FDA Inspection 1193902 - 2022-12-01
- FDA Inspection 1053505 - 2018-05-25
- FDA Inspection 1014496 - 2017-03-30
- FDA Inspection 991913 - 2016-11-04
- FDA Inspection 871964 - 2014-02-28
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