FDA Inspection
California Pharmacy & Compounding CenterCalifornia Pharmacy & Compounding Center – FDA Inspection, Aug 25, 2014
Record Details
This FDA Inspection record concerns California Pharmacy & Compounding Center, with an inspection on August 25, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- August 25, 2014
- Product Type
- Drugs
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ID · 16534f70-05cc-47c0-b00b-7a2e3054f568
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 893386
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
14- 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 211.167(a)Sterility/pyrogen-free testing
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.186(a)Written procedures followed
- 21 CFR 211.166(a)Results not used for expiration dates, storage cond.
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Other FDA inspections of California Pharmacy & Compounding Center
4| Date | Classification | Office | Project area |
|---|---|---|---|
| December 17, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 21, 2017 | Not classified | Los Angeles District Office | Drug Quality Assurance |
| August 31, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 17, 2014 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for California Pharmacy & Compounding Center
- FDA Inspection 1074872 - 2018-12-17
- FDA Inspection 1013560 - 2017-04-21
- FDA Inspection 986751 - 2016-08-31
- FDA Inspection 900112 - 2014-10-17
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