FDA WARNING_LETTER - Intersurgical, Ltd. - July 14, 2011

An FDA inspection of Intersurgical, Ltd. in Wokingham, UK, from July 11-14, 2011, identified significant violations in the manufacture of single-use, non-sterile medical devices. The firm's products were deemed misbranded under Section 502(t)(2) of the Act due to a failure to furnish required information under Section 519, specifically regarding Medical Device Reporting (MDR). A key violation was the firm's failure to develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17, mistakenly believing its U.S. affiliate handled all reporting. Additionally, the inspection revealed quality system deficiencies under Section 501(h) and 21 CFR Part 820. These included the failure to adequately control labeling and packaging operations to prevent mix-ups (21 CFR 820.120(d)), evidenced by incorrect labels in Device History Records. In-process testing for certain materials was not performed according to work instructions, and failures were not properly documented or investigated. Furthermore, the firm failed to establish and maintain procedures to control all documents required by the Quality System Regulation (21 CFR 820.40), with unvalidated and unapproved manufacturing setting changes noted. Intersurgical, Ltd. must provide a written response within fifteen business days detailing specific corrective actions, preventative measures, and a timetable. Failure to correct these violations may impact federal contracts, premarket approvals for Class III devices, and the granting of Certificates to Foreign Governments, indicating broader issues within the firm's quality management systems.