FDA Inspection
Pine Pharmacy and Home Care Products Center, Inc.Pine Pharmacy and Home Care Products Center, Inc. – FDA Inspection, Dec 16, 2013
Record Details
This FDA Inspection record concerns Pine Pharmacy and Home Care Products Center, Inc., with an inspection on December 16, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- December 16, 2013
- Product Type
- Drugs
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ID · e8527bdd-e816-409e-9a2a-e02668be5782
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 858280
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.166(b)Adequate number of batches on stability
- 21 CFR 211.28(a)Clothing appropriate for duties performed
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.166(a)Results not used for expiration dates, storage cond.
- 21 CFR 211.42(c)Defined areas of adequate size for operations
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Other FDA inspections of Pine Pharmacy and Home Care Products Center, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 19, 2013 | OAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
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