CooperSurgical, Inc. D.B.A. Lone Star Medical Products – FDA Warning Letter, Aug 6, 2012

The FDA issued a Warning Letter to CooperSurgical, Inc. following an inspection of its Lone Star Medical Products facility in Stafford, Texas, from July 10 to August 6, 2012. The inspection revealed that Uterine Manipulator Handle, Koh-Efficient, and Stays devices are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820). The firm's August 27, 2012, response was deemed inadequate due to a lack of supporting evidence for promised corrections.

Key violations include: 1. **Failure to maintain complaint files and procedures (21 CFR 820.198(a))**: Examples include not utilizing the MDR Determination Form for complaints involving vaginal lacerations, failing to document efforts to obtain information or retrieve products, and not documenting previous similar events. 2. **Failure to investigate complaints (21 CFR 820.198(c))**: A mislabeling issue for Lone Star Stays lacked documented investigation or corrective action. 3. **Failure to promptly review and identify MDR-reportable complaints (21 CFR 820.198(d))**: A complaint involving a broken RUMI II Handle, reported by a user facility to FDA, lacked a documented rationale for