FDA Inspection
Hartley Medical Center Pharmacy, IncorporatedHartley Medical Center Pharmacy, Incorporated – FDA Inspection, Jul 8, 2015
Record Details
This FDA Inspection record concerns Hartley Medical Center Pharmacy, Incorporated, with an inspection on July 8, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- July 8, 2015
- Product Type
- Drugs
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ID · db6c2f5b-e277-4af1-8ae6-a030e7d362bc
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 934241
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.28(a)Clothing appropriate for duties performed
- 21 CFR 211.167(a)Sterility/pyrogen-free testing
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.113(b)Validation lacking for sterile drug products
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Other FDA inspections of Hartley Medical Center Pharmacy, Incorporated
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 24, 2017 | Not classified | Los Angeles District Office |
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