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USFDA issued form 483 to Halol Facility of Sun Pharma on account of cGMP violations

Sun Pharma's Halol Facility located in Gujarat has received form 483 on account of cGMP violations. The USFDA conducted a pre-approval inspection (PAI) of the Halol facility and found non-compliance with cGMP regulations. The inspection was carried out from 27th August 2018 to 31ST August 2018.

Six observations were cited in form 483 to which Sun Pharma said that it will respond to the observations within two weeks.

The observations were related to

deficiencies of certain test procedures related to laboratory control,

not following procedures to prevent objectionable microorganisms

lack of written procedures for production and process control

procedures not followed for cleaning and maintenance of equipment and quality control unit Sun Pharma is committed to addressing these observations promptly with corrective and preventive action plan. The Halol site had received an establishment inspection report (EIR) from USFDA three months ago only due to which the plant started receiving approvals of USFDA after a span of five years.