FDA Inspection
Defender SD Manufacturing LLCDefender SD Manufacturing LLC – FDA Inspection, May 11, 2017
Record Details
This FDA Inspection record concerns Defender SD Manufacturing LLC, with an inspection on May 11, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
View Company Profile
ID · 0a3f1fa2-0fda-4632-819d-d5ca0587c7b1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1022371
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.48(a)Plumbing System Defects
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
Full citation text and observation details available on the Dashboard.
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 |
| 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 |
Other documents for Defender SD Manufacturing LLC
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.