FDA Inspection
Auro Pharmacies, Inc DBA Central DrugsAuro Pharmacies, Inc DBA Central Drugs – FDA Inspection, Dec 2, 2016
Record Details
This FDA Inspection record concerns Auro Pharmacies, Inc DBA Central Drugs, with an inspection on December 2, 2016, issued by the Los Angeles District Office, covering human drugs.
- People
- Evelyn W. Ladines (Issuing Officer)
- Uttaniti Limchumroon (FDA Associated Person)
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ID · 63e8731c-46a8-41f9-b413-152b3ad64574
Inspection Facts
- Inspection number
- 994358
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
16- 21 CFR 211.111Establishment of time limitations
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.122(a)Written procedures describing in detail
- 21 CFR 211.130Procedures are written, and followed
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.167(a)Sterility/pyrogen-free testing
- 21 CFR 211.192No written record of investigation
- 21 CFR 211.22(a)Authority lacking to review records, investigate errors
Showing 10 of 16 citations.
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Other FDA inspections of Auro Pharmacies, Inc DBA Central Drugs
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 18, 2019 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 29, 2017 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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