FDA Inspection
Phoenix Innovative Healthcare Manufacturers Private LimitedPhoenix Innovative Healthcare Manufacturers Private Limited – FDA Inspection, Sep 27, 2024
Record Details
This FDA Inspection record concerns Phoenix Innovative Healthcare Manufacturers Private Limited, with an inspection on September 27, 2024, issued by the Office of Inspections and Investigations, covering human drugs.
- Inspection Date
- September 27, 2024
- Product Type
- Human Drugs
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ID · a1eac585-957c-46c7-a6fe-df6064075a93
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1250191
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.103Actual vs. theoretical yields not determined
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.170(b)Reserve samples identified, representative, stored
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.63Equipment Design, Size and Location
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Other FDA inspections of Phoenix Innovative Healthcare Manufacturers Private Limited
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 22, 2024 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 27, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 21, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Phoenix Innovative Healthcare Manufacturers Private Limited
- FDA Inspection 1252466 - 2024-08-22
- FDA Inspection 1108987 - 2019-09-27
- FDA Inspection 993547 - 2016-10-21
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