Shilpa Medicare gets 5 USFDA observations for Raichur facility
"We have received Form 483 with five observations, with no repeat observations and any data integrity observations. The observations are mostly procedural in nature," the Shilpa Medicare added.
Raichur: Drug firm Shilpa Medicare on Monday said it has received five observations from the US health regulator for its Raichur facility after the completion of an inspection.
"We have completed USFDA (United States Food and Drug Administration) audit at our API (active pharmaceutical ingredient) site, Raichur between July 22-26, 2019," Shilpa Medicare said in a filing to the BSE.
"We have received Form 483 with five observations, with no repeat observations and any data integrity observations. The observations are mostly procedural in nature," the company added.
As per the USFDA, observations are made in Form 483 when investigators feel that conditions or practices in the facility are such that products may become adulterated or render injuries to health.
The FDA Form 483 notifies the company's management of objectionable conditions.
Shilpa Medicare Limited (SML) started its operations as API manufacturer way back in 1987 at Raichur, Karnataka- India. The commercial production in the SML was started in November 1989.