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FDA Inspection
•Snowberry New Zealand Ltd•November 6, 2014

Snowberry New Zealand Ltd – FDA Inspection, Nov 6, 2014

Record Details

This FDA Inspection record concerns Snowberry New Zealand Ltd, with an inspection on November 6, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Snowberry New Zealand Ltd
Inspection Date
November 6, 2014
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · 3e0a4807-7217-4881-8108-dac3471c3ad9

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
908147
FDA center
Human Drugs
Project area
Drug Quality Assurance

FDA Citations

5
  1. 21 CFR 211.87Retest of approved components/containers/closures
  2. 21 CFR 211.186(b)(9)Complete instructions, procedures, specifications et. al.
  3. 21 CFR 211.84(d)(2)Reports of Analysis (Components)
  4. 21 CFR 211.165(a)Testing and release for distribution
  5. 21 CFR 211.166(a)Lack of written stability program

Full citation text and observation details available on the Dashboard.

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