During March 18-21, 2014 the FDA inspected the pharmaceutical manufacturing facility, Unimark Remedies Ltd., located at 337 Kerala Nalsarovar Road, Kerala Village, Bavla, Ahmedabad District, India. The FDA identified significant deviations from current good manufacturing practice (CGMP) for the manufacture of active pharmaceutical ingredients (APIs). These deviations caused … [Read more...]
ZHEJIANG JIUZHOU PHARMACEUTICAL CO., LTD. (CHINA) RECEIVES WARNING LETTER (7/09/14)
APIs WERE MISBRANDED Zhejiang Jiuzhou Pharmaceutical Co., Ltd. (China) was inspected from October 21-24, 2013 at their active pharmaceutical ingredient manufacturing facility. Deviations from CGMP were noted in the manufacture of the API. “Failure to implement an effective system of managing quality and failure to transfer all quality or … [Read more...]
Indian Mexican API Facilities Cited by FDA in Warning Letter
Dr. Reddy's Laboratories Found in Non-Compliance and In Receipt of an Import Ban Comment Dr Reddy's Mexico facilities were inspected between November 8-11, 2010. During the audit the FDA identified significant deviations from CGMP for the manufacture of APIs. These deviations caused the APIs to be adulterated. A response dated December 1, 2010, received by the Agency, … [Read more...]
