Shilpa Medicare facility suffers 3 power cuts in 15 minutes, receives Form 483

02-Sep-2019 - Last updated on 02-Sep-2019 at 09:10 GMT

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Related tags Shilpa Medicare Form 483 Fda

The US FDA issues a Form 483 to Shilpa Medicare, after an investigation noted five observations that require action, including an unreliable power supply.

Shilpa Medicare, an Indian manufacturer of active pharmaceutical ingredients (APIs) and formulations, received a Form 483 from the US Food and Drug Administration (FDA) after an inspection in late July.

The form outlines the issues at the company’s Raichur, India, facility, which includes the observation that during a walkthrough by the investigators, “three power failures occurred with the facility during a 15-minute interval.”

In addition, the power failures were compounded by the inability of the back-up generator to restore power.

The other observations noted by the FDA included a failure to thoroughly review out-of-spec batches, missing equipment used in the manufacture of intermediates and APIs, and insufficient cleaning of equipment and utensils.

Following the FDA’s inspection, Shilpa posted an update to the Bombay Stock Exchange (BSE), stating, "We have received Form 483 with five observations, with no repeat observations and any data integrity observations. The observations are mostly procedural in nature."

Shares in Shilpa have fallen by 27%, as of the time of writing, after it released first-quarter results reporting a 55% fall in year-on-year net profit. The company posted an update to the BSE, explaining that the movement of its share price could be ‘largely attributed’ to its financials.