FDA Inspection
Auro Pharmacies, Inc DBA Central DrugsAuro Pharmacies, Inc DBA Central Drugs – FDA Inspection, Oct 18, 2019
Record Details
This FDA Inspection record concerns Auro Pharmacies, Inc DBA Central Drugs, with an inspection on October 18, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- October 18, 2019
- Product Type
- Drugs
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ID · f26cf1da-adc2-4b49-8b87-ea3038da9877
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1107187
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Enforcement
- Amended 483
FDA Citations
11- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.84(d)(2)Establish reliability of supplier"s C of A
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.67(b)(5)Cleaning SOPs/equipment protection
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.22(a)Authority lacking to review records, investigate errors
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.80(b)Handling and Storage to Prevent Contamination
- 21 CFR 211.165(d)Acceptance/Rejection Levels
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Other FDA inspections of Auro Pharmacies, Inc DBA Central Drugs
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 29, 2017 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 2, 2016 | Not classified | Los Angeles District Office | Drug Quality Assurance |
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