Shilpa Medicare sheds nearly 5% on USFDA observations

Shares of Shilpa Medicare declined 5.65 per cent intraday on Wednesday as the company has received 10 observations from USFDA.

After opening the session weak at Rs 605.60 against the previous close of Rs 635.15, the scrip touched an intraday high of Rs 615.05 and a low of Rs 599.25. In terms of equity volume, 0.17 lakh shares exchanged hands in the evening trade.

Shilpa Medicare shares ended the session down by 4.73 per cent at Rs 605.10 on the BSE.

According to a BSE filing,

Shilpa Medicare has received 483 observations from the United States Food & Drug Administration (USFDA) in relation to SEZ formulation facilities situated at Jadcherla, Telangana (near Hyderabad).

The company has received total 10 observations, which includes 7 observations for improvement in procedures and practices and 3 observations are related to setting of analytical specifications, test procedures and method validation.

USFDA communicates any deviations in manufacturing practices observed during the inspection on Form 483. Typically, the company needs to respond to USFDA within a period of 15 days with a corrective action plan.