FDA Inspection
Triangle Compounding Pharmacy IncTriangle Compounding Pharmacy Inc – FDA Inspection, Mar 1, 2013
Record Details
This FDA Inspection record concerns Triangle Compounding Pharmacy Inc, with an inspection on March 1, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- March 1, 2013
- Product Type
- Drugs
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ID · 1e889749-9328-43d3-b332-6077142f5082
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 821119
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.42(c)Defined areas of adequate size for operations
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.192Investigations of discrepancies, failures
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Other FDA inspections of Triangle Compounding Pharmacy Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| April 4, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 13, 2017 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 16, 2015 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 22, 2014 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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