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...]
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, including Salmonella, Clostridium difficile, Klebsiella pneumoniae and Pseudomonas … [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...]
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 advising health care professionals and patients not to use any liquid product … [Read more...]
