FDA Inspection
Defender SD Manufacturing LLCDefender SD Manufacturing LLC – FDA Inspection, Feb 2, 2011
Record Details
This FDA Inspection record concerns Defender SD Manufacturing LLC, with an inspection on February 2, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- February 2, 2011
- Product Type
- Drugs
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ID · b4fa50c7-ec56-4054-89e6-9a7da9112515
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 709731
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.67(b)(6)Cleaning SOP/inspection
- 21 CFR 211.184(c)Individual inventory record
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.42(c)(2)Rejected Material Area
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.22(c)Approve or reject procedures or specs
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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 |
| November 3, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 18, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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