FDA Inspection
Mallikatta Neuro Research CentreMallikatta Neuro Research Centre – FDA Inspection, Nov 25, 2016
Record Details
This FDA Inspection record concerns Mallikatta Neuro Research Centre, with an inspection on November 25, 2016, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · d6c2a5b5-d503-4b9b-ac80-c580772dc9d1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1010682
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 312.62(b)Case history records- inadequate or inadequate
- 21 CFR 312.64(b)Safety reports
- 21 CFR 312.66Changes in research
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