FDA Slams Hetero For Oversized Tablets And Dirty Equipment
In a recent FDA warning letter to Hetero Labs in Hyderabad, India, investigators chastise the firm for lax GMP practices. Hetero joins a growing number of manufacturers in the city that have been targeted by FDA and EU regulators for GMP violations this year.
You may also be interested in...
A review of recent US FDA citations has industry concerned about the extent to which agency investigators may be reviewing security video archives as part of their pharmaceutical manufacturing plant inspections.
Pressure builds on Dr Reddy’s Laboratories after at least two US law firms press ahead with a class action case against the company. Analysts appear unperturbed, however – at least for now – about the possibility of any material implications.
Dr. Reddy’s compliance woes hit a new low, with the German regulator stopping supplies to the EU from the firm’s Bachupally unit over significant GMP deviations. Worse still, some foreign investor rights law firms appear to be pressing for a class action suit against the company.