FDA Inspection
New Era NaturalsNew Era Naturals – FDA Inspection, Apr 13, 2018
Record Details
This FDA Inspection record concerns New Era Naturals, with an inspection on April 13, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · d799e905-4630-48c9-8185-ce845b6112f8
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1048376
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
- Enforcement
- Warning Letter
FDA Citations
13- 21 CFR 211.84(d)(2)Component written specification
- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.84(d)(1)Component identity verification
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.186(b)(9)Complete instructions, procedures, specifications et. al.
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.165(a)Testing and release for distribution
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Other FDA inspections of New Era Naturals
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 25, 2018 | Not classified | Denver District Office |
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