FDA Inspection
Salt Chamber, LLCSalt Chamber, LLC – FDA Inspection, Nov 19, 2015
Record Details
This FDA Inspection record concerns Salt Chamber, LLC, with an inspection on November 19, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Salt Chamber, LLC
- Inspection Date
- November 19, 2015
- Product Type
- Drugs
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ID · c79c162a-fa1b-42ad-9ab8-adfb379f9200
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 949884
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
17- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.84(d)(2)Testing Each Component for Conformity with Specs
- 21 CFR 820.170(a)Lack of or inadequate instructions
- 21 CFR 211.186(b)(9)Complete instructions, procedures, specifications et. al.
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.142Written warehousing procedures established/followed
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of Salt Chamber, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 5, 2013 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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