Company Cited for Failure to Follow Numerous Medical Device cGMP Regulations
A warning letter released to the public 23 April cites medical device manufacturer Ad-Tech Medical Instrument Corporation for failure to follow medical device regulations established by the US Food and Drug Administration (FDA).
The company, which manufactures devices for neurological monitoring and neurosurgery, was hit with a bevy of regulatory citations by FDA, which noted the company's products were "not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation."
Among the main complaints leveled at Ad-Tech by FDA:
- failure to establish adequate procedures for design changes
- failure to establish adequate procedures for design review
- failure to adequately document and approve process validation activities and results
- failure to establish adequate procedures for corrective and preventive action
- failure to establish adequate procedures for rework of nonconforming product,
- failure to establish adequate procedures for changes to a specification and procedure
- failure to establish adequate procedures to control product that does not conform to specified requirements
FDA's warning letter noted an addition 19 sub-points of deficiencies.
While Ad-Tech reportedly responded to FDA in March, FDA notes the firm's "FDA Excellence in 2012" program has not yet been completed, and the firm faces stiff penalties if it fails to comply.
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