FDA Inspection
Clinical Specialties Compounding PharmacyClinical Specialties Compounding Pharmacy – FDA Inspection, Apr 2, 2013
Record Details
This FDA Inspection record concerns Clinical Specialties Compounding Pharmacy, with an inspection on April 2, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- April 2, 2013
- Product Type
- Drugs
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ID · cada16fc-5241-422f-b2d2-6cf2e66b427f
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 827045
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
11- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.150(b)Recall facilitation
- 21 CFR 211.198(b)Maintenance of Complaint File
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.42(b)Product flow through building is inadequate
- 21 CFR 211.25(c)Inadequate number of personnel
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