FDA Inspection
Defender SD Manufacturing LLCDefender SD Manufacturing LLC – FDA Inspection, Nov 3, 2014
Record Details
This FDA Inspection record concerns Defender SD Manufacturing LLC, with an inspection on November 3, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- November 3, 2014
- Product Type
- Drugs
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ID · 2ef85401-ece1-4560-ad12-2c497d321229
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 902146
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.160(a)Deviations from laboratory control requirements
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.186(b)(7)Theoretical yield statement including percentages
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.80(b)Handling and Storage to Prevent Contamination
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Other FDA inspections of Defender SD Manufacturing LLC
8| Date | Classification | Office | Project area |
|---|---|---|---|
| September 22, 2022 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 12, 2018 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 11, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 18, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 9, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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