FDA Inspection
California Pharmacy & Compounding CenterCalifornia Pharmacy & Compounding Center – FDA Inspection, Apr 21, 2017
Record Details
This FDA Inspection record concerns California Pharmacy & Compounding Center, with an inspection on April 21, 2017, issued by the Los Angeles District Office, covering human drugs.
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ID · 92105a8f-62c2-4924-873a-0f97c70088da
Inspection Facts
- Inspection number
- 1013560
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
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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 |
| 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 |
| August 25, 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 986751 - 2016-08-31
- FDA Inspection 900112 - 2014-10-17
- FDA Inspection 893386 - 2014-08-25
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