FDA Inspection
NEW WORLD HEALTHCARE PRIVATE LIMITEDNEW WORLD HEALTHCARE PRIVATE LIMITED – FDA Inspection, Sep 13, 2019
Record Details
This FDA Inspection record concerns NEW WORLD HEALTHCARE PRIVATE LIMITED, with an inspection on September 13, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · a1b3e640-b656-4cf7-b37d-6264991c0467
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1101849
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.165(d)Acceptance criteria for sampling & testing
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.194(a)(4)Complete Test Data
- 21 CFR 211.134(b)Representative samples after completion
- 21 CFR 211.184(b)Component Test Records
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.110(b)In-process conformity - examination, sample testing
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