FDA Inspection
Aidance Skincare and Topical Solutions, LLCAidance Skincare and Topical Solutions, LLC – FDA Inspection, Aug 31, 2018
Record Details
This FDA Inspection record concerns Aidance Skincare and Topical Solutions, LLC, with an inspection on August 31, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · db6937e9-1802-4af5-8dce-0525e08041a5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1064405
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
13- 21 CFR 211.170(a)Active ingredient retained sample kept
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.84(d)(3)Container/Closure Written Test Procedure
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.46(b)Equipment for Environmental Control
- 21 CFR 211.84(d)(2)Establish reliability of supplier"s C of A
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.84(d)(1)Identity Testing of Each Component
- 21 CFR 211.192Investigations of discrepancies, failures
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Other FDA inspections of Aidance Skincare and Topical Solutions, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 12, 2025 | VAI | New England District Office | Drug Quality Assurance |
| March 30, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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