In Brief: Abaxis
This article was originally published in The Gray Sheet
Abaxis: Firm's manufacturing facility receives Good Manufacturing Practices "in-compliance" letter from FDA, the company says Sept. 9. The correspondence resolves issues raised in a warning letter Abaxis received during its first fiscal quarter (ended June 30) relating to deficiencies in manufacturing software validation documentation. The renewed status clears the way for FDA to resume review of Abaxis' 510(k) for its gamma glutamyl transferase (GGT) test, part of the firm's Piccolo Hepatic Function Panel...
You may also be interested in...
The Environmental Working Group and Scientific Analytical Institute say inadequate testing of talc-containing personal-care products is to blame for findings of asbestos in cosmetics, including three of 21 powder-based cosmetics SAI analyzed at EWG’s request. They continue to push for updated testing standards that include electron microscopy as a core component.
Can Atlas Biomed unlock Japan's self-care market with its direct-to-consumer DNA and microbiome tests? HBW Insight catches up with the company's co-founder and CEO to discuss this and also how Atlas has been driving its European expansion plans despite coronavirus.
France's ANSES warns women using oral contraceptives not to use a supplement marketed by UK firm Hairburst after linking the product's consumption to two cases of severe acute hepatitis.