GMP TRENDS, INC. | Example - Medical Device Manufacturing Controls


DISTRICT ADDRESS GMP Trends Inc. P.O. Box 8001 Boulder, Colorado 80306			DATE OF ISSUE Introductory
			C.I. ISSUE Issue # MMXIX
NAME AND TITLE OF INDIVIDUAL TO WHOM REPORT ISSUED To: Responsible Person, Director of Quality Assurance
FIRM NAME Pharmaceutical and Related Industries		STREET ADDRESS 5600 Regulation Lane
CITY, STATE AND COUNTRY United States of America and Worldwide		TYPE OF ESTABLISHMENT INSPECTED Pharmaceutical and Related Industries
During a review of inspection reports of U.S. firms (i) (we) observed: EDITED EXCERPTS FROM ACTUAL 483 OBSERVATION REPORTS BY FOOD AND DRUG ADMINISTRATION INVESTIGATORS Medical Device Manufacturing Controls .....The design history file does not demonstrate that the design was developed following the requirements of 21 CFR 820. Specifically, the design control procedure (SOP .....) requires the Director of Quality, Director of Operations, Plant Manager, and other participants (as needed) to be present during design reviews. However, there is no documented requirement within this procedure that each design review include an individual who does not have direct responsibility for the design stage being reviewed be present. .....Quality audits were not conducted at sufficient regular intervals, as prescribed by internal procedures to verify that the quality system is effective in fulfilling your quality system objectives. Specifically, review of the Internal Audit Schedule does not indicate a scheduled audit for manufacturing processes and process validation of manufacturing processes. The firm’s failure analysis results provided indicators of potential processing problems with test results identifying residual moisture in hermetically sealed devices. There was no modification of the Internal Audit Schedule to audit or re-audit: management controls; design controls; CAPA procedures; failure investigation procedures; manufacturing production and process controls; process validations and other quality system requirements to identify potential deficiencies that could account for residual moisture is finished devices. .....The procedures for implementing corrective and preventive actions (CAPA) were not complete. Specifically, your firm has not established procedures for implementing corrective and preventive actions (CAPA) which include the requirements for: Analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems. Investigating the cause of nonconformities relating to the product, processes and the quality system. Identifying the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems. Verifying or validating the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device. Implementing and recording changes in methods and procedures needed to correct and prevent identified quality problems. Submitting relevant information on identified quality problems, as well as corrective and preventive actions, for management review. .....Complaint handling procedures for receiving, reviewing, and evaluating complaints have not been completed. Specifically, both, the Worldwide Complaint Handling Procedure, SOP ....., and the Adverse Event Handling Procedure for Marketed Products, SOP ....., do not ensure that complaints that represent an event which must be reported to FDA under part 803. A record of the investigation shall include a determination of whether the device failed to meet specifications. In addition, SOP ..... does not reflect the current Medical Device Reporting (MDR) regulation in that it does not describe the different types of report submission, including the use of Form ..... (MEDWATCH), Baseline and Supplemental Reports.
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Medical Device Manufacturing Controls

.....The design history file does not demonstrate that the design was developed following the requirements of 21 CFR 820.

.....Quality audits were not conducted at sufficient regular intervals, as prescribed by internal procedures to verify that the quality system is effective in fulfilling your quality system objectives.

.....The procedures for implementing corrective and preventive actions (CAPA) were not complete.

.....Complaint handling procedures for receiving, reviewing, and evaluating complaints have not been completed.