FDA Inspection
Itrace Pharmaceutical Solutions Private LimitedItrace Pharmaceutical Solutions Private Limited – FDA Inspection, Nov 15, 2024
Record Details
This FDA Inspection record concerns Itrace Pharmaceutical Solutions Private Limited, with an inspection on November 15, 2024, issued by the Office of Inspections and Investigations, covering human drugs.
- Inspection Date
- November 15, 2024
- Product Type
- Human Drugs
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ID · a5ab5b9c-4944-4f57-8434-e357f8282926
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1254312
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 211.63Equipment Design, Size and Location
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