FDA Inspection
The Wellness Center Pharmacy, Inc., dba Designer DrugsThe Wellness Center Pharmacy, Inc., dba Designer Drugs – FDA Inspection, May 28, 2015
Record Details
This FDA Inspection record concerns The Wellness Center Pharmacy, Inc., dba Designer Drugs, with an inspection on May 28, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- May 28, 2015
- Product Type
- Drugs
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ID · d3bbeac4-e87b-43f7-8aab-99686eca6861
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 929306
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
14- 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
- 21 CFR 211.28(a)Clothing appropriate for duties performed
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.84(d)(2)Testing Each Component for Conformity with Specs
- 21 CFR 211.46(b)Equipment for Environmental Control
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.113(b)Validation lacking for sterile drug products
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Other FDA inspections of The Wellness Center Pharmacy, Inc., dba Designer Drugs
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 22, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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