FDA Inspection
Dorneyville PharmacyDorneyville Pharmacy – FDA Inspection, Jan 7, 2016
Record Details
This FDA Inspection record concerns Dorneyville Pharmacy, with an inspection on January 7, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Dorneyville Pharmacy
- Inspection Date
- January 7, 2016
- Product Type
- Drugs
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ID · 618ec289-6eaf-496f-bcdd-2c676fb3cf1e
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 957597
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
14- 21 CFR 211.87Retest of approved components/containers/closures
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.28(a)Clothing appropriate for duties performed
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.167(a)Sterility/pyrogen-free testing
- 21 CFR 211.84(a)Components withheld from use pending release
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.113(b)Procedures for sterile drug products
Showing 10 of 14 citations.
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Other FDA inspections of Dorneyville Pharmacy
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 28, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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