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§ 820.200 Servicing.
(a) Where servicing is a specified requirement, each manufacturershallestablish and maintain instructions and procedures for performing and verifying that the servicing meets the specified requirements.
(b) Each manufacturershall analyze service reports with appropriate statistical methodology in accordance with § 820.100.
(c) Each manufacturer who receives a service report that represents an event which must be reported to FDA under part 803 of this chapter shall automatically consider the report a complaint and shall process it in accordance with the requirements of § 820.198.
(d) Service reports shall be documented and shall include: