FDA Inspection
Beacon Hill Medical Pharmacy, P.C.Beacon Hill Medical Pharmacy, P.C. – FDA Inspection, Jul 19, 2013
Record Details
This FDA Inspection record concerns Beacon Hill Medical Pharmacy, P.C., with an inspection on July 19, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- July 19, 2013
- Product Type
- Drugs
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ID · 6303cb71-2df2-4182-9144-211a0b8ceb9f
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 841366
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
13- 21 CFR 211.94(c)Containers & Closures Clean, Sterilized, Pyrogen-free
- 21 CFR 211.167(a)Sterility/pyrogen-free testing
- 21 CFR 211.84(a)Components withheld from use pending release
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.100(a)Absence of Written Procedures
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