483
Centrient Pharmaceuticals India Private LimitedCentrient Pharmaceuticals India Private Limited – FDA 483, Jan 27, 2026
Record Details
Centrient Pharmaceuticals India Private Limited in Toansa, India, received a Form 483 with three observations related to significant manufacturing deficiencies. The inspection revealed severe issues with equipment cleaning, leading to cross-contamination and residual materials, as well as failures in preventing contamination of APIs by foreign particles from worn equipment and inadequate environmental monitoring. These issues pose a substantial risk to product quality and patient health.
- Inspection date
- January 27, 2026
- Product type
- drugs
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ID · 6339f67d-3661-4b03-9ff4-0ea6ed8d84d5
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