FDA 483 - FIAB spa - May 16, 2024

FIAB spa, a medical device manufacturer in Vicchio, Florence, Italy, was inspected by the FDA and received a Form 483 with four observations. The inspection revealed significant deficiencies in the firm's quality system, including inadequate documentation of acceptance activities, poorly established purchasing procedures, insufficient maintenance of quality system records, and inadequate complaint handling procedures, specifically regarding Unique Device Identification (UDI) recording.