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Pharmaceuticals / Inspections and Audits

Arch Pharmalabs Cited for Water Quality, Computer Problems

March 15, 2017
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Arch Pharmalabs received a Form 483 from the FDA listing numerous problems including water quality, documentation and computer system issues.

After an inspection of the API manufacturer’s facility in Thane, India, the agency found the company could not ensure the quality of water used in the manufacturing process.

The agency also cited the firm’s failure to control computerized systems to safeguard against unauthorized changes to data.

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