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

By Ben Hargreaves contact

- Last updated on GMT

(Image: Getty/Tiero)
(Image: Getty/Tiero)

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.

Related news

Related products

How to resolve sticking issues in tablet production

How to resolve sticking issues in tablet production

I Holland Limited - Tabletting Science | 24-Jun-2019 | Case Study

Tablet sticking is one of the most common problems in tablet manufacture. Find out how I Holland used the TSAR scientific predictive model and expert tablet...

How to measure powder and granule flow properties

How to measure powder and granule flow properties

Stable Micro Systems | 01-Apr-2019 | Technical / White Paper

Being able to predict, optimise and control powder flow is of prime importance to manufacturers in ensuring high quality standards. Download this free...

Strategies to Select and Deliver the Right Candidate

Strategies to Select and Deliver the Right Candidate

Catalent Pharma Solutions | 05-Mar-2018 | Technical / White Paper

Does your candidate have what it takes to succeed? Do you have the information needed to make the right decisions about your candidate’s path to the clinic?...

Related suppliers

Follow us

Products

View more

Webinars