The Medicines and Healthcare Products Regulatory Agency (MHRA) has issued a recall notice to Allergen Limited. The recall notice relates to 5g and 3.5g pack sizes of
USFDA (Food and Drug Administration) issues import ban for products manufactured by Polydrug Laboratories. It was issued on Sept. 11, 2015 for
Health Canada has lifted its ban from Apotex two Indian facilities. Canada’s drug regulator reinspected the two plants in June and determined
Recently Karnataka drug control department had conducted surprise inspections to pick up drug samples at random. The drug test labs have issued their result.
Vivimed Labs has recently successfully completed inspection of its API manufacturing facility in Spain. After the completion of inspection Vivimed said “the USFDA inspectors concluded
GMP News & Guidelines Archives:
USFDA (Food and Drug Administration) has issued Insulet Corp Form 483 over some insulin pumps. Insulet official said “The letter relates to the release of certain lots of the company's EROS OmniPods that did not conform to the FDA's final acceptance criteria”. The lots were manufactured in mid-2013 and the first half of 2014. A Form 483 is usually issued at the end of an inspection when the investigator finds out violation of prescribed standards. The company said the letter, which it received on 8th June followed an inspection by the FDA of its facility in Billerica, Massachusetts in March. Insulet said it expects the letter will not have any adverse impact on its operations.
Insulet’s OmniPod System is a completely unique approach offering all the benefits of insulin pump therapy, with none of issues.