FDA Inspection
Triangle Compounding Pharmacy IncTriangle Compounding Pharmacy Inc – FDA Inspection, Jul 13, 2017
Record Details
This FDA Inspection record concerns Triangle Compounding Pharmacy Inc, with an inspection on July 13, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- Adam R. Cooke (FDA Associated Person)
- Rachael L. Derby (Issuing Officer)
- Seneca D. Toms
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ID · 7778835e-ad3a-44e2-a930-836300399049
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1017932
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
11- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.94(b)Protection from external factors
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.84(e)Rejecting When Specifications Not Met
- 21 CFR 211.130(b)Unlabeled filled containers controls
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.165(a)Testing and release for distribution
- 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 |
| 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 |
| March 1, 2013 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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