FDA Inspection
Colonia Care PharmacyColonia Care Pharmacy – FDA Inspection, Jul 26, 2021
Record Details
This FDA Inspection record concerns Colonia Care Pharmacy, with an inspection on July 26, 2021, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Colonia Care Pharmacy
- Inspection Date
- July 26, 2021
- Product Type
- Drugs
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ID · 3d6ae74a-4655-43e0-a73a-c88004223adc
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1147167
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Enforcement
- 483 Response
FDA Citations
3- Non-microbial contamination, production area
- Inadequate sporicidal agents, cleanroom and ISO 5 area
- Highly potent drugs, prevention of cross-contamination
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Other FDA inspections of Colonia Care Pharmacy
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 22, 2019 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 15, 2016 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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