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.
The firm’s quality unit failed to confirm the resolution of all investigations and to update a batch manufacturing record that was not properly documented. Inspectors further found the facility failed to ensure that its raw materials were not contaminated during transfer from its warehouse to its production facility.
In addition, Arch could not demonstrate the scientific soundness of its testing procedures.
The company did not respond to a request for comment.
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