FDA Inspection
Neutraderm Inc.Neutraderm Inc. – FDA Inspection, Dec 2, 2011
Record Details
This FDA Inspection record concerns Neutraderm Inc., with an inspection on December 2, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Neutraderm Inc.
- Inspection Date
- December 2, 2011
- Product Type
- Drugs
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ID · 7849c8bb-b8fb-4796-8865-5302c250b89d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 754210
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
14- 21 CFR 211.166(b)Adequate number of batches on stability
- 21 CFR 211.188(b)(8)Labeling control records including specimens or copies
- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.180(e)Records reviewed annually
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.84(b)Representative Samples Criteria
- 21 CFR 211.22(c)Approve or reject procedures or specs
- 21 CFR 211.22(a)Approve or reject components, products
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Other FDA inspections of Neutraderm Inc.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| June 15, 2026 | Not classified | Los Angeles District Office | |
| December 9, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 14, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 22, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 26, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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