FDA WARNING_LETTER - Leisegang Feinmechanik-Optik GmbH - April 19, 2012

On July 11, 2012, the FDA issued a Warning Letter to Leisegang Feinmechanik-Optik GmbH following an inspection from April 16-19, 2012, in Berlin, Germany. The inspection revealed that the firm's Leisegang Optik Model 1 and 2 colposcopes are adulterated under 21 U.S.C. § 351(h) because their manufacturing, packing, storage, or installation methods do not conform to the Quality System (QS) regulation (21 CFR Part 820). The devices are also misbranded under 21 U.S.C. § 352(t)(2) due to failure to furnish required information under 21 U.S.C. § 360i and 21 CFR Part 803 (Medical Device Reporting - MDR).

Key violations include: 1. Failure to establish and maintain adequate CAPA procedures (21 CFR 820.100(a)), with the existing manual being inadequate and a specific complaint's corrective action lacking verification/validation. 2. Failure to establish and maintain adequate complaint handling procedures (21 CFR 820.198(a)), specifically regarding timeliness, MDR evaluation, investigation, and recordkeeping. 3. Failure to review and evaluate all complaints to determine