FDA Inspection
Developmental Natural Resources, Inc.Developmental Natural Resources, Inc. – FDA Inspection, Sep 13, 2013
Record Details
This FDA Inspection record concerns Developmental Natural Resources, Inc., with an inspection on September 13, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- September 13, 2013
- Product Type
- Drugs
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ID · d01e7b19-b9c5-4ee6-a108-7bbd5e4cea96
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 853761
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
13- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.150(b)Distribution Recall System
- 21 CFR 211.84(d)(1)Identity Testing of Each Component
- 21 CFR 211.186(b)(9)Manufacturing Instructions and Specifications
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 111.27(b)Instruments - calibration
- 21 CFR 111.103Written procedures - quality control operations
- 21 CFR 111.70(b)(1)Specifications - component identity
- 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
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Other FDA inspections of Developmental Natural Resources, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 17, 2015 | VAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
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