FDA Inspection
Defender SD Manufacturing LLCDefender SD Manufacturing LLC – FDA Inspection, Sep 22, 2022
Record Details
This FDA Inspection record concerns Defender SD Manufacturing LLC, with an inspection on September 22, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- September 22, 2022
- Product Type
- Drugs
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ID · bf4437f4-6d02-4274-82a8-9ef5c6e8af59
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1180152
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.22(a)Authority lacking to review records, investigate errors
- 21 CFR 211.100(a)Absence of Written Procedures
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Other FDA inspections of Defender SD Manufacturing LLC
8| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| February 9, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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