FDA Inspection
Universal Packaging Systems, Inc. dba PakLabUniversal Packaging Systems, Inc. dba PakLab – FDA Inspection, Dec 22, 2015
Record Details
This FDA Inspection record concerns Universal Packaging Systems, Inc. dba PakLab, with an inspection on December 22, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- December 22, 2015
- Product Type
- Drugs
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ID · bf36e170-6af3-45ac-ac7e-447792db4c10
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 953161
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.160(a)Deviations from laboratory control requirements
- 21 CFR 211.160(b)(4)Establishment of calibration procedures
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.192No written record of investigation
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Other FDA inspections of Universal Packaging Systems, Inc. dba PakLab
5| Date | Classification | Office | Project area |
|---|---|---|---|
| May 29, 2025 | VAI | Los Angeles District Office | Drug Quality Assurance |
| November 17, 2023 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 17, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 25, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 21, 2009 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Universal Packaging Systems, Inc. dba PakLab
- FDA Inspection 1271195 - 2025-05-29
- FDA Inspection 1223081 - 2023-11-17
- FDA Inspection 1203142 - 2023-03-17
- FDA Inspection 1062443 - 2018-07-25
- FDA Inspection 598205 - 2009-07-21
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