FDA Inspection
Partners In Care, Inc.Partners In Care, Inc. – FDA Inspection, Jun 10, 2016
Record Details
This FDA Inspection record concerns Partners In Care, Inc., with an inspection on June 10, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Partners In Care, Inc.
- Inspection Date
- June 10, 2016
- Product Type
- Drugs
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ID · bb1ece08-e6ed-44fa-952d-bd917d6affdc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 983425
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.80(b)Handling and Storage to Prevent Contamination
- 21 CFR 211.80(a)Procedures To Be in Writing
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Other FDA inspections of Partners In Care, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 7, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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