Endoscopy Products Maker Warned Over Quality, Recordkeeping Lapses
The FDA handed Encompas Unlimited a warning letter for failures in quality control, implementation of medical device reporting procedures and incomplete device history records.
Procedures to control nonconforming products — specifically, ES-50 Endo Scrub devices used for precleaning equipment and instruments — are inadequate, according to the Feb. 20 letter. Encompas’ purchasing control procedure doesn’t define the type and extent of control to be exercised over products and vendors based on an evaluation of noncomforming products.
The Sarasota, Fla., devicemaker revised its purchasing control procedures, but these procedures still don't define the extent of control based on suppliers’ ability to meet the devicemaker’s requirements, the investigator notes. The warning letter follows a Nov. 10 to 18, 2014, inspection by the FDA’s Florida district office.
Encompas also lacks an approved supplier list or established criteria for critical vendors. Meanwhile, long-time vendors appear to have been grandfathered in, the letter notes. The investigator also raps the firm for failing to maintain device history records and for lacking written procedures showing devices are made in accordance with current good manufacturing practices
For example, records for inspection and production of the Endo Scrub between mid-July 2003 and October 2014 don’t list manufacturing codes or lot numbers for finished devices. The FDA also faults Encompas’ complaint-handling procedures, because they don’t require evaluation of complaints to determine if they are MDR reportable.
Encompas declined to comment on the letter. Read it at www.fdanews.com/03-17-15-Encompas.pdf — Charlotte Astor