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...]
Ps. Aeruginosa Exceeds 2.1 X 107/Gm in Product; Where was the Microbiologist?
Questions often arise regarding when is a microorganism “specified” vs. “objectionable”? USP<62> lists a total of seven individual and groups of microorganisms to include Ps. aeruginosa that are considered “specified”. However, in a broader category they are also considered as “objectionable”. A recent Warning Letter discusses the microbiological results from a … [Read more...]
