The following is the second Blog in an on-going series of Blogs obtained from a Warning Letter about Mylan Laboratories, Bangalore, India as well as other Mylan (Agila Specialties Private Ltd.) facilities in India. This second Blog continues the review of the Mylan facilities which were audited February 6-13, 2015 and are located at Plot No. 284-B (19A) Bommasandra Jigani Link … [Read more...]
HAMELN PHARMACEUTICALS, HAMELN, GERMANY RECEIVES WARNING LETTER (12/17/12)
IN-HOUSE STERILITY TESTING METHOD NOT EQUIVALENT TO USP<71> During the time frame of June 4 - 14, 2012, the Hameln facility was audited by the FDA. Following the audit, the firm responded on July 4, August 2 and 31, and September 8, 2012. Even with all of these responses, the FDA found that the firm lacked sufficient corrective actions. For … [Read more...]
