US FDA finds IPCA Labs' Silvassa unit non-compliant with cGMP

Ipca Laboratories announced that the United States Food and Drug Administration (FDA) has found its manufacturing unit in Silvassa, Gujarat, non-compliant with the current good manufacturing practices (cGMP).

The company further added that since this manufacturing facility is already under US FDA import alert and presently not doing any US business, this will have no impact on company's current on-going business activities.

"We have received a communication from US FDA that they have determined the inspection classification of Piparia (Silvassa) formulations manufacturing facility as "Official Action Indicated (OAI)" and that that this facility is considered to be in an unacceptable state of compliance with regards to current good manufacturing practice (CGMP)," the company said in a filing.

US FDA inspection of its Piparia (Silvassa) formulations manufacturing unit in August, resulted into three observations, the company added.

Comments

Post a Comment

Popular posts from this blog

Updated Ph. Eur. Chapter on plastic containers

A revised version of Ph. Eur. chapter 3.2.2. Plastic containers and closures for pharmaceutical use has been published in Pharmeuropa, Issue 31.4. The deadline for comments is 31 December 2019. In the revised version the list of commonly used polymers has been replaced with a cross-reference to "Materials used for the manufacture of containers" (Ph. Eur. 3.1 and subsections) to take into account additional materials that will be included in the future (e.g. 3.1.17 "Cyclo-olefin copolymers (COC)" and 3.1.18 "Styrene block copolymers for containers and closures for parenteral preparations and ophthalmic preparations", as previously announced in the Ph. Eur. Work Programme of March 2019). In addition, editorial changes have been made throughout the general chapter, including a change in the French title. Furthermore, in August 2019, a new Ph. Eur. Chapter with the title: 2.4.35 "Extractable elements in plastic materials for pharmaceutical use" has b...
Read more

Dr. Stephen Hahn Nominated to Head FDA

Radiation oncology expert Stephen Hahn, M.D., has been nominated as the new U.S. Food and Drug Administration commissioner. Hahn, 59, is chief medical executive of The University of Texas MD Anderson Cancer Center in Houston, and he has been a professor of radiation oncology there since January 2015, CNN reported. Ned Sharpless, M.D., acting commissioner of the FDA, will return to his role as the director of the U.S. National Cancer Institute, the U.S. Department of Health and Human Services said. The FDA has a $5.7 billion budget and more than 17,000 employees, CNN reported.
Read more