US FDA Regulatory reporting and change control findings

An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

Your outsourcing facility compounds drug products using bulk drug substances that cannot be used in compounding under section 5038 because they (a) are not used to compound drug products that appear on the drug shortage list in effect under section 506E of the Act and (b) do not appear on a list developed by FDA of bulk drug substances for which there is a clinical need.

Written procedures have not been developed for the reporting to FDA of post marketing adverse drug experiences.

An annual report was not submitted within 60 days of the anniversary date of U.S.

An MDR report was not submitted within 30 days ofreceiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

Your outsourcing facility compounds drug products using bulk drug substances that cannot be used in compounding under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they (a) are not used to compound drug products that appear on the drug shortage list in effect under section 506E of the Act and (b) do not appear on a list developed by FDA of bulk drug substances for which there is a clinical need.