Enclosed are a series of upcoming microbiological related webinars which are being offered between now and the middle of June. While many of us are working from home or in the office on a limited basis, this represents a great opportunity to either gain new skills or refresh those that may require refreshing. Just click on the title of each webinar to gain … [Read more...]
Daito Kasei Kogyo Co., LTD., Receives Warning Letter (January 18, 2018) for Failure to Conform to Specifications (reference 21 CFR 211.160 and 165)
The U.S. Food and Drug Administration (FDA) inspected Daito Kasei Kogyo Co., LTD. from July 18 to 21, 2017. They subsequently were placed on an Import Alert 66-40 on October 25, 2017 and received a Warning Letter on January 19, 2018. During the inspection, the investigator observed specific deviations including, but not limited to, the following. Failure to … [Read more...]
U.S. Food and Drug Administration (FDA) Inspection Cites Chinese Firm for API Issues – Includes Import Alert and Warning Letter
The U.S. Food and Drug Administration (FDA) inspected manufacturing facilities,  Changzhou Jintan Qianyao Pharmaceutical Raw Materials, from February 13-17, 2017. As a result of significant deviations from current good manufacturing practice (CGMP), the FDA placed the firm on Import Alert 66-40 on May 4, 2017. Subsequent to … [Read more...]
NIPPON FINE CHEMICAL CO RECEIVES IMPORT ALERT AND WARNING LETTER FOR REFUSAL TO ADMIT
Nippon Fine Chemical recently received a Form FDA 483 (December 14, 2015), followed by an Import Alert (August 8, 2016) and a Warning Letter (Click Here) (September 26, 2016) for adulterated products that were produced at their drug manufacturing facility, Nippon Fine Chemical Co., Ltd, located at 1-1, 5-Chome, Umei, Takasago City, Hyogo. The FDA investigator documented that … [Read more...]
PAN DRUGS LTD, INDIA, RECEIVES WARNING LETTER (090215) FOLLOWING THE RECEIPT OF AN IMPORT ALERT
An inspection of Pan Drugs LTD, Gujarat, India from July 14-18, 2014 lead to serious deviations that caused their APIs to be adulterated in that the methods used in, or the facilities or controls used for, their manufacture, processing, packing or holding do not conform to, or are not operated or administered in conformity with cGMP. COMMENT: Pan Drugs was placed on … [Read more...]
