FDA Inspection
Specialty Compounding, LLCSpecialty Compounding, LLC – FDA Inspection, Mar 22, 2013
Record Details
This FDA Inspection record concerns Specialty Compounding, LLC, with an inspection on March 22, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Specialty Compounding, LLC
- Inspection Date
- March 22, 2013
- Product Type
- Drugs
View Company Profile
ID · ab58336a-c074-4637-b9cf-d70c3627ee03
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 824156
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 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 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.166(a)Lack of written stability program
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Other FDA inspections of Specialty Compounding, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 5, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 13, 2013 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Specialty Compounding, LLC
- FDA Inspection 925132 - 2015-05-05
- FDA Inspection 848733 - 2013-09-13
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