FDA Inspection
Defender SD Manufacturing LLCDefender SD Manufacturing LLC – FDA Inspection, Jun 18, 2013
Record Details
This FDA Inspection record concerns Defender SD Manufacturing LLC, with an inspection on June 18, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- June 18, 2013
- Product Type
- Drugs
View Company Profile
ID · 43e0c44f-2661-48e4-9c66-72b16ca1454e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 837628
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.22(b)Adequate lab facilities not available
- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.42(c)(10)(iii)Air Supply
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.160(b)Scientifically sound laboratory controls
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 |
| 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 |
| 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.