FDA Inspection
Specialty Medicine Compounding Pharmacy, P.C.Specialty Medicine Compounding Pharmacy, P.C. – FDA Inspection, Nov 5, 2013
Record Details
This FDA Inspection record concerns Specialty Medicine Compounding Pharmacy, P.C., with an inspection on November 5, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- November 5, 2013
- Product Type
- Drugs
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ID · 084ada79-27a0-4c03-a75d-201698cde5ec
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 854148
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.166(b)Adequate number of batches on stability
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.100(a)Absence of Written Procedures
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