The US Food and Drug Administration (FDA) has issued six observations on Sun Pharma's Mohali plant and has critiqued procedures and lab tests. The inspection took place from August 3 to August 12.

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CNBC-TV18 has accessed these observations, which say that Sun Pharma's Mohali plant failed to review unexplained discrepancies raised by the drug regulator earlier.

The USFDA goes on to say that sampling plans, test procedures, and lab control mechanisms were not documented properly. Additionally, written procedures were not drafted, reviewed, and approved.

The USFDA has found that lab records were deficient and did not include a complete record. This includeed the fact that lab controls did not have established appropriate test procedures, and written procedures were not followed for the testing of components.

The pharma stock slipped in early trade and was down nearly 2 percent from its highs after this news broke.

Sun Pharma reported a 43 percent growth in consolidated net profit for the April-June quarter earlier this month.

Brokerages have been bullish on the stock in the recent past.

Just a week back, generic drug makers Glenmark, Sun Pharma, Dr Reddy's and Jubilant Cadista recalled multiple products in the US market, the world's largest market for medicines, for various issues.

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(Edited by : Abhishek Jha)

First Published:Aug 19, 2022 12:09 PM IST