FDA Inspection
Defender SD Manufacturing LLCDefender SD Manufacturing LLC – FDA Inspection, Mar 12, 2018
Record Details
This FDA Inspection record concerns Defender SD Manufacturing LLC, with an inspection on March 12, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 5cfa4a74-8a75-43db-8f14-30fbb0d7af6d
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1043973
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.192No written record of investigation
- 21 CFR 211.192Written record of investigation incomplete
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.25(c)Inadequate number of personnel
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.56(c)Written procedures lacking for use of pesticides etc.
- 21 CFR 211.67(b)(3)Cleaning SOPs/instructions
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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 |
| 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 |
| February 9, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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