483
Phoenix Innovative Healthcare Manufacturers Private LimitedPhoenix Innovative Healthcare Manufacturers Private Limited – FDA 483, Sep 27, 2024
Record Details
Phoenix Innovative Healthcare Manufacturers Private Limited, a drug manufacturer in Navi Mumbai, India, was inspected and received a Form 483 with six observations. The inspection revealed significant deficiencies in laboratory controls, quality unit investigations, sample retention, production record-keeping, yield reconciliation, and equipment suitability. These issues indicate a lack of robust quality systems and control over manufacturing processes.
- Inspection date
- September 27, 2024
- Product type
- drugs
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ID · 56d07290-83a1-465f-83a2-1b8bde6546f7
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