FDA WARNING_LETTER - FSSB Chirurgische Nadeln Gmbh - September 20, 2012

On January 29, 2013, the FDA issued a Warning Letter to FSSB Chirurgische Nadeln GMBH following an inspection from September 17-20, 2012, in Jestetten, Germany. The firm manufactures sterile and non-sterile needles and sutures, classified as devices under section 201(h) of the Act. The inspection revealed these devices are adulterated per section 501(h) due to non-conformity with Quality System (QS) regulation, 21 CFR Part 820.

Violations include: 1. Failure to control nonconforming product (21 CFR 820.90): The firm's procedure for nonconforming material was not followed, nonconformances during needle production were undocumented, and disposition of nonconforming needles lacked control, documentation, evaluation, or corrective/preventive actions. 2. Failure to evaluate complaints for Medical Device Reporting (MDR) (21 CFR 820.198(a)(3)): The complaint procedure did not require evaluation to determine if events necessitated an MDR submission. 3. Failure to validate computer software (21 CFR 820.70(i)): Software validation for custom automatic needle production machines was performed but not documented. 4. Failure to establish statistical techniques for process and product acceptability (21 CFR