Halol Plant of SUN Pharma may get an Import Alert. The US FDA did an inspection at SUN Pharma’s Halol Plant in the last few days. As reported by Business Standard and Money Control SUN Pharma was taken by surprise when 5 FDA inspectors walked in on Monday September 11, 2014. In earlier reports it was stated that FDA 483 observations were received for its plant at Karkhadi in Gujarat, India> It was commented that ... “We expect other plants of SUN Pharma to face import alert sooner than later. SUN Pharma stock will also face a crash similar to that seen for Ranbaxy and Wockhardt in the next 3 to 6 months. Today the stock of SUN Pharma has crashed by more than 5 %. In a Warning Letter released by FDA for its Karkhadi Plant, FDA citations make it clear that the major reason for issuing an import for that plant was data fraud. FDA has recommended SUN Pharma to appoint a Data Integrity consultant and has advised among other things to identify any historical period(s) during which inaccurate data reporting occurred at SUNs facilities. Identify and interview current employees who were employed prior to, during, or immediately after the relevant period(s) to identify activities, systems, procedures, and management behaviors that may have resulted in or contributed to inaccurate data reporting. Identify former employees who departed prior to, during, or after the relevant periods and make diligent efforts to interview them to determine whether they possess any relevant information regarding any inaccurate data reporting. Determine whether other evidence supports the information gathered during the interviews, and determine whether additional facilities were involved in or affected by inaccurate data reporting. Use organizational charts and SOPs to identify the specific managers in place when the inaccurate data reporting was occurring and determine the extent of top and middle management involvement in, or awareness of, data manipulation. Determine whether any individual managers are still in a position to influence data integrity with respect to CGMP requirements or data submitted to the agency. Expand internal review to any other facilities determined to be involved in, or affected by, inaccurate data reporting. The media reported that an import alert for the plant at Halol is expected very soon....
Posted on: Tue, 16 Sep 2014 15:26:22 +0000
Trending Topics
Recently Viewed Topics
© 2015