FDA Inspection
Neutraderm Inc.Neutraderm Inc. – FDA Inspection, Sep 14, 2018
Record Details
This FDA Inspection record concerns Neutraderm Inc., with an inspection on September 14, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · c5e83dd9-bb07-4f93-85c2-254ec0b240d3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1065592
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.22(b)Adequate lab facilities not available
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.180(e)Records reviewed annually
- 21 CFR 211.160(b)(2)In-process samples representative, identified properly
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.67(b)Written procedures not established/followed
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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 |
| 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 |
| December 2, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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