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...]
Les Produits Chimiques B.G.R., Inc. Receives FDA Warning Letter (07/24/2018) for Failure to Perform Laboratory Testing
Les Produits Chimiques B.G.R., Inc. Receives FDA Warning Letter (07/24/2018) for Failure to Perform Laboratory Testing. The U.S. Food and Drug Administration (FDA) inspected Les Produits Chimiques B.G.R., Inc., Pointe-Claire, Quebec, from September 25 to 27, 2017. A Warning Letter was issued which contained significant deviations from current good manufacturing practice … [Read more...]
Milbar Laboratories Receives Warning Letter (July 23, 2018) for Failure to Meet Purified Water Specifications
Milbar Laboratories Receives Warning Letter (July 23, 2018) for Failure to Meet Purified Water Specifications. The U.S. Food and Drug Administration (FDA) inspected Milbar Laboratories located at 20 Commerce Street, East Haven, CT from December 7–27, 2017. On July 23, 2018 they received a Warning Letter based on their audit. Several notable Observations included those … [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...]
Celltrion Inc, Republic of Korea, Receives Warning Letter for Microbiological/Environmental Issues
The U.S. Food and Drug Administration (FDA) inspected Celltrion Inc, Republic of Korea from May 22 – June 2, 2017. On January 26, 2018 the FDA issued a Warning Letter for microbiological/environmental issues that summarizes significant violations of cGMP for finished pharmaceuticals (see 21 CFR, parts 210/211). Several … [Read more...]
