FDA Inspection
Isomeric Pharmacy Solutions, LLCIsomeric Pharmacy Solutions, LLC – FDA Inspection, Jun 29, 2016
Record Details
This FDA Inspection record concerns Isomeric Pharmacy Solutions, LLC, with an inspection on June 29, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- June 29, 2016
- Product Type
- Drugs
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ID · fa558fd3-d7c2-4ddd-a933-2dbfb0b608a9
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 976852
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.166(b)Adequate number of batches on stability
- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.42(c)(10)Aseptic Processing Area
- Drug product label, outsourcer facility
- 21 CFR 211.111Establishment of time limitations
- 21 CFR 211.192Written record of investigation incomplete
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Other FDA inspections of Isomeric Pharmacy Solutions, LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 12, 2017 | Not classified | Denver District Office | |
| March 24, 2017 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 28, 2015 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Isomeric Pharmacy Solutions, LLC
- FDA Inspection 1030573 - 2017-10-12
- FDA Inspection 1005888 - 2017-03-24
- FDA Inspection 944241 - 2015-08-28
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