Hexagon Analytical Solutions Private Limited – FDA 483, Jun 5, 2026
Hexagon Analytical Solutions Private Limited in Ahmedabad, India, a contract laboratory, was cited for deficiencies in its quality control unit's written procedures. The inspection revealed issues with change control for newly acquired laboratory equipment, inadequate cleaning instructions for the water system, and a lack of proper documentation and effectiveness checks for the pest control program. These findings indicate a failure to establish and follow written procedures for critical quality control responsibilities.
ID · 7d0b3509-b1ff-4e23-af7e-aa9325490f48
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