FDA Inspection
Specialty Compounding, LLCSpecialty Compounding, LLC – FDA Inspection, Sep 13, 2013
Record Details
This FDA Inspection record concerns Specialty Compounding, LLC, with an inspection on September 13, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Specialty Compounding, LLC
- Inspection Date
- September 13, 2013
- Product Type
- Drugs
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ID · a4a94447-ec8b-49bf-9bef-2ee300afaf26
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 848733
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
15- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.188(b)(9)Description of containers and closures
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.28(a)Clothing appropriate for duties performed
- 21 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.167(a)Sterility/pyrogen-free testing
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.184(c)Individual inventory record
- 21 CFR 211.165(a)Testing and release for distribution
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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 |
| March 22, 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 824156 - 2013-03-22
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