Schroeder Industries, Inc. – FDA Warning Letter, Jun 3, 2008

An FDA inspection of Schroeder Industries, Inc. dba Schroeder America, Inc. on May 22 and June 3, 2008, revealed that the firm manufactures brass rounds used for patient radiation therapy, which are considered medical devices. The inspection found these devices adulterated under section 501(h) of the Act, 21 U.S.C. § 351(h), due to non-conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation, 21 C.F.R. Part 820. Key violations identified include failures to adequately validate manufacturing processes, revalidate processes after changes, establish process control procedures, establish procedures for verifying/validating changes, maintain equipment procedures, establish procedures for acceptance of incoming product, and establish procedures for Device History Records (DHRs). The firm was instructed to take prompt corrective action within fifteen working days, providing a detailed plan and timetable. Failure to comply could lead to regulatory actions such as seizure, injunction, civil money penalties, impact on federal contracts, and denial of premarket approvals or Certificates to Foreign Governments. The letter emphasizes that the listed violations may indicate broader quality system issues requiring thorough investigation and correction.