FDA Inspection
Pine Pharmacy and Home Care Products Center, Inc.Pine Pharmacy and Home Care Products Center, Inc. – FDA Inspection, Jul 19, 2013
Record Details
This FDA Inspection record concerns Pine Pharmacy and Home Care Products Center, Inc., with an inspection on July 19, 2013, issued by the Center for Veterinary Medicine, covering veterinary.
- Inspection Date
- July 19, 2013
- Product Type
- Veterinary
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ID · ab8db657-0f5c-4ebc-b2e8-3c1a9d4fa2e3
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 841175
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
FDA Citations
10- 21 CFR 211.46(c)Exhaust systems inadequate to control air contamination
- 21 CFR 211.22(b)Adequate lab facilities not available
- 21 CFR 211.166(b)Adequate number of batches on stability
- 21 CFR 211.28(a)Clothing appropriate for duties performed
- 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 211.113(b)Validation lacking for sterile drug products
- 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 |
|---|---|---|---|
| December 16, 2013 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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