FDA Inspection
Coast Quality Pharmacy, LLCCoast Quality Pharmacy, LLC – FDA Inspection, May 7, 2018
Record Details
This FDA Inspection record concerns Coast Quality Pharmacy, LLC, with an inspection on May 7, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- Christie A. Garcia (Issuing Officer)
- Jennifer L. Huntington (FDA Associated Person)
- Joanne E. King (FDA Associated Person)
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ID · 3d30c358-c8c8-45e6-a487-382ddc49b122
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1051024
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
13- 21 CFR 211.42(c)(10)(iii)Air Supply
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- FDCA 501(a)(2)(A)Disinfecting materials, aseptic processing area
- 21 CFR 211.192Extent of discrepancy, failure investigations
- FDCA 501(a)(2)(A)Improper gowning, contamination
- FDCA 501(a)(2)(A)Disruption of airflow from personnel movement
- 21 CFR 211.113(b)Procedures for sterile drug products
- FDCA 501(a)(2)(A)Dust-collecting overhangs, surrounding area of ISO 5
- 21 CFR 211.166(a)(3)Valid stability test methods
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Other FDA inspections of Coast Quality Pharmacy, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 9, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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