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March 31, 2020
Paragon Cited for Lax Procedures
FDA investigators also observed that the facility’s equipment was not routinely calibrated.
March 27, 2020
Contract Manufacturer Falls Flat on Complaints, Training
Device contract manufacturer Minnesota MedTec was found to be lax in training its production staff and handling customer complaints, according to a Form 483 received following an inspection of the firm’s Maple Grove, Minnesota facility.
March 27, 2020
Ineffective CAPA, Quality Audits Dog Surgical Instrument Maker
Inadequate corrective and preventive actions were a repeat observation that came up in an inspection of Keystone Manufacturing’s Kalamazoo, Michigan facility.

March 27, 2020
Contract Manufacturer Paragon Fails to Control Product
March 27, 2020
FDA Taps International Ties to Keep Foreign Inspections Afloat
March 19, 2020
FDA Finds Multiple Quality Failures for 3D-Printed Orthodontic Devices
March 19, 2020
FDA Suspends Domestic Inspections as Coronavirus Outbreak Spreads
March 18, 2020
FDA Faults Biomedix for Weak Process Validation

March 17, 2020
Oxus Cited for CAPA Failures
March 13, 2020
Oxygen Supplier Lacks Effective CAPA Procedures
March 13, 2020
Lax Process Validation Results in Quality Failures at Biomedix
March 13, 2020
Numerous Quality Failures Uncovered for 3D-Printed Orthodontic Devices
March 13, 2020
Rhode Island Firm Draws Warning for Design Controls

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