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Houston-based medical devicemaker Talon received a lengthy FDA warning letter for design process and quality control issues following an inspection of the firm’s manufacturing facility. Read More
Lusys Laboratories: A 16-item Form 483 highlighted a litany of QMS lapses uncovered at Lusys Laboratories’ San Diego, California plant during a Jan. 22-Feb. 7 FDA inspection. Read More
CAPA, complaint handling, acceptance activity and purchasing control procedures had been developed but were not implemented, the agency reported. Read More
The agency said that personnel with knowledge of the firm’s market withdrawals, submissions and design controls were not present during the inspection to explain the basis for the market withdrawal of a pregnancy test. Read More