FDA Inspection
Native Remedies, LLCNative Remedies, LLC – FDA Inspection, Mar 15, 2013
Record Details
This FDA Inspection record concerns Native Remedies, LLC, with an inspection on March 15, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Native Remedies, LLC
- Inspection Date
- March 15, 2013
- Product Type
- Drugs
View Company Profile
ID · d8e7ef64-d49c-4612-9fd0-c99fe73d3227
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 822977
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 111.553Written procedures - product complaint
- 21 CFR 111.70(b)(3)Specifications - contamination limits
- 21 CFR 111.455(a)Hold - temperature, humidity, light
- 21 CFR 111.75(a)(2)(ii)(A)Component - qualify supplier
- 21 CFR 111.127Quality control operations - packaging, labeling
- 21 CFR 111.105(a)Quality control - processes, specifications, written procedures
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