FDA 483 - Blickman Industries LLC - August 20, 2021
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Blickman Industries LLC, a manufacturer and distributor of medical metal stands, carts, tables, and cabinetry in Clifton, NJ, received a Form 483 citing significant deficiencies in its quality system. The inspection revealed a lack of established procedures for Unique Device Identification (UDI) and inadequate supplier management, including insufficient documentation of supplier agreements and audits. Additionally, the firm failed to submit a Medical Device Report (MDR) for a serious injury and exhibited poor document control with unauthorized personnel approving critical revisions.
ID · 2384a1cf-55a0-47e5-a426-dcff857911e7