FDA Inspection
US Compounding IncUS Compounding Inc – FDA Inspection, Feb 7, 2019
Record Details
This FDA Inspection record concerns US Compounding Inc, with an inspection on February 7, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · cd451fd0-78c6-48fa-90ed-db640615c24b
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1078477
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 211.42(c)(10)(i)Floors, walls, ceiling surfaces
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- FDCA 503B(a)(10)Drug product label, outsourcer facility
- 21 CFR 211.22(a)Approve or reject components, products
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.166(a)(3)Valid stability test methods
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Other FDA inspections of US Compounding Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 15, 2016 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 21, 2015 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 27, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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