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GMP Violation noted by FDA at US vascular medical device manufacturing unit

Updated: Nov 23, 2018

As per the reports, during an inspection of US vascular's medical device manufacturing facility at Beaverton by US FDA, there have been 11 contraventions of good manufacturing practices, as per a FDA warning letter.

Earlier in April 2017, there were 11 repeated observation of the firm out of 12 inspectional citations marked in FDA form 483. FDA also added that in the recent investigation there was a repetition of 8 of the citation from March 2016 inspection.

A warning letter was issued to the premises as the observation in Form 483 was notable GMP violation. Some of the GMP violations mentioned in the warning letter issued to US vascular who manufactures class II pathology devices were associated with improper steps for design control, CAPA corrective and preventive actions executions, supervision of non-conforming products, evaluation of supplier, handling of the complaint and device master record and history record maintenance.

As per the warning letter, the firm was also quoted for absence of procedure for accepting incoming products, internal quality audit conduction and control of documents. The firm also tried to convince FDA about their concerns by asserting that they have executed some new procedures on assessment of supplier and control of document on the same day when FDA’s inspection was started.

For now, firm had to implement some procedure for adverse drug reporting at the FDA’s visit time. The firm has also been informed by the FDA previously to include the reviews for reporting of medical devices under 21 CFR part 803 or 21 CFR part 820.198 “by mentioning Citation on FDA for 483 during your last three inspections” the agency quoted. “Adequate corrections have not been received by the agency to date.

FDA aims at reviewing the action of the firm for addressing each of the violation, as a part of its next inspection.