FDA Inspection
Private Label Partners, Inc.Private Label Partners, Inc. – FDA Inspection, Jun 17, 2016
Record Details
This FDA Inspection record concerns Private Label Partners, Inc., with an inspection on June 17, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Private Label Partners, Inc.
- Inspection Date
- June 17, 2016
- Product Type
- Drugs
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ID · b4e0360d-b88b-4a50-bd7e-4630c9250550
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 976055
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.188(a)Accurate reproduction
- 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
- 21 CFR 211.80(b)Handling and Storage to Prevent Contamination
- 21 CFR 211.42(c)Defined areas of adequate size for operations
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.110(a)Written in-process control procedures
- 21 CFR 211.192No written record of investigation
- 21 CFR 211.182Written records kept in individual logs
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Other FDA inspections of Private Label Partners, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| January 17, 2025 | OAI | Los Angeles District Office | Drug Quality Assurance |
| September 13, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 14, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 8, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 13, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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