Enclosed are a series of upcoming microbiological webinars which are being offered between now and the end of September. 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 … Read More...
Microbiological Webinars
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 … Read More...
Microbiological Webinars 2020 (Upcoming)
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 … Read More...
General Chapter (USP<60>) on B. cepacia Complex to Issue December 1, 2019
Pharmacopeial Forum (PF, September/October 2018, 44(5)) published a new, proposed General Chapter (USP<60>) on B. cepacia Complex entitled “USP<60> Microbiological Examination of Nonsterile Products—Tests for Burkholderia cepacia Complex”. The proposed PF chapter represents an expansion … 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 … 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 … 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 … Read More...
FDA advises consumers not to use Blissful Remedies kratom products due to bacterial contamination 7/05/2018
FDA advises consumers not to use Blissful Remedies kratom products due to bacterial contamination. The products are sold by World Organix LLC, Las Vegas, Nevada. FDA laboratory analysis found that the products are contaminated with high counts of various bacteria that can cause infections, … 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 … Read More...
Burkholderia cepacia Contamination Creates Recall Situation (08082017)
FDA advises health care professionals and patients not to use any liquid drug products manufactured by PharmaTech and distributed by Rugby Laboratories and possibly other companies CDC lab testing detects product contamination, links products to patient infections [8/8/2017]Â FDA is … Read More...
