FDA Inspection
Dr. Reddy's Laboratories Louisiana LLCDr. Reddy's Laboratories Louisiana LLC – FDA Inspection, Sep 6, 2013
Record Details
This FDA Inspection record concerns Dr. Reddy's Laboratories Louisiana LLC, with an inspection on September 6, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- September 6, 2013
- Product Type
- Drugs
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ID · e3363266-6888-4e43-984d-90c145153483
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 848808
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
14- 21 CFR 211.198(b)Written complaint record to be maintained at facility
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.160(a)Deviations from laboratory control requirements
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.186(a)Written procedures followed
- 21 CFR 211.89Quarantine of Rejected Components et. al.
- 21 CFR 211.22(a)Authority lacking to review records, investigate errors
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Other FDA inspections of Dr. Reddy's Laboratories Louisiana LLC
7| Date | Classification | Office | Project area |
|---|---|---|---|
| August 8, 2019 | Not classified | New Orleans District Office | |
| February 21, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 10, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 21, 2012 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 13, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Dr. Reddy's Laboratories Louisiana LLC
- FDA Inspection 1105481 - 2019-08-08
- FDA Inspection 1084860 - 2019-02-21
- FDA Inspection 951182 - 2015-11-10
- FDA Inspection 802097 - 2012-09-21
- FDA Inspection 768648 - 2012-02-13
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