FDA Inspection
Universal Packaging Systems, Inc. dba PakLabUniversal Packaging Systems, Inc. dba PakLab – FDA Inspection, May 29, 2025
Record Details
This FDA Inspection record concerns Universal Packaging Systems, Inc. dba PakLab, with an inspection on May 29, 2025, issued by the Los Angeles District Office, covering human drugs.
- Inspection Date
- May 29, 2025
- Product Type
- Human Drugs
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ID · 6295a6c3-0243-4799-9261-956f424038d8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1271195
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.142Written warehousing procedures established/followed
- 21 CFR 211.166(a)(2)Stability sample storage conditions described
- 21 CFR 211.166(a)(3)Valid stability test methods
- 21 CFR 211.22(a)Approve or reject components, products
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
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Other FDA inspections of Universal Packaging Systems, Inc. dba PakLab
5| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| December 22, 2015 | VAI | 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 1223081 - 2023-11-17
- FDA Inspection 1203142 - 2023-03-17
- FDA Inspection 1062443 - 2018-07-25
- FDA Inspection 953161 - 2015-12-22
- FDA Inspection 598205 - 2009-07-21
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