FDA Inspection
Colonia Care PharmacyColonia Care Pharmacy – FDA Inspection, Apr 15, 2016
Record Details
This FDA Inspection record concerns Colonia Care Pharmacy, with an inspection on April 15, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Colonia Care Pharmacy
- Inspection Date
- April 15, 2016
- Product Type
- Drugs
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ID · 9cf9b308-55c6-434e-ae47-284808fd28f9
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 984885
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.94(b)Protection from external factors
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.166(a)Lack of written stability program
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Other FDA inspections of Colonia Care Pharmacy
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 26, 2021 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 22, 2019 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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