FDA Inspection
Dermaceutical Laboratories, LLCDermaceutical Laboratories, LLC – FDA Inspection, Apr 6, 2015
Record Details
This FDA Inspection record concerns Dermaceutical Laboratories, LLC, with an inspection on April 6, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- April 6, 2015
- Product Type
- Drugs
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ID · 8b4a30e0-def1-48b9-bbc8-3369e2feb6b9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 921048
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.198(b)Written complaint record to be maintained at facility
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.46(c)Air filtration system lacking in production area
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
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Other FDA inspections of Dermaceutical Laboratories, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 1, 2024 | VAI | New Jersey District Office | Drug Quality Assurance |
| March 16, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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