FDA Inspection
American Specialty PharmacyAmerican Specialty Pharmacy – FDA Inspection, Dec 19, 2014
Record Details
This FDA Inspection record concerns American Specialty Pharmacy, with an inspection on December 19, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- American Specialty Pharmacy
- Inspection Date
- December 19, 2014
- Product Type
- Drugs
View Company Profile
ID · 38f16fda-5723-41db-8277-116f5663037f
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 908694
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.42(c)(10)(vi)Equipment to control conditions
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.28(a)Clothing appropriate for duties performed
- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.167(a)Sterility/pyrogen-free testing
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.166(a)Lack of written stability program
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