FDA Inspection
Universal Packaging Systems, Inc. dba PakLabUniversal Packaging Systems, Inc. dba PakLab – FDA Inspection, Mar 17, 2023
Record Details
This FDA Inspection record concerns Universal Packaging Systems, Inc. dba PakLab, with an inspection on March 17, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · f2dc1657-ceaa-4628-abac-dd4079e4d777
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1203142
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.84(d)(2)Component identification test
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.84(d)(2)Component identification test
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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 |
| 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 1271195 - 2025-05-29
- FDA Inspection 1223081 - 2023-11-17
- FDA Inspection 1062443 - 2018-07-25
- FDA Inspection 953161 - 2015-12-22
- FDA Inspection 598205 - 2009-07-21
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