Inspections, Compliance, Enforcement, and Criminal Investigations
MicroSurgical Technologies, Inc. 01-Mar-06
Department of Health and Human Services
Public Health Service
March 1, 2006
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 06-19
Edmund H. Terpilowski, President
MicroSurgical Technologies, Inc.
8415 154 Avenue NE
Redmond, WA 98052
Dear Mr. Terpilowski:
On November 8-10, 14-16, and 21, 2005, a Food and Drug Administration (FDA) investigator conducted an inspection of your establishment located at 8415 154th Avenue NE, Redmond, Washington. FDA has determined that your establishment manufacturers two ophthalmic surgical devices, the Phaco Needles and Tips and Oculo-Pressor, which are medical devices under section 201(h) [21 U.S.C. 321(h)] of the Federal Food, Drug, and Cosmetic Act (the Act). We acknowledge the receipt of your response dated January 3, 2006, but that response was not adequate.
Our inspection revealed that these devices are adulterated within the meaning of section 501 h) of the Act [21 U.S.C. 351(h)] in that the methods used in, or the facilities or controls used for manufacturing, packing, storage, or installation are not in conformance with the current Good Manufacturing Practice (cGMP) requirements of the Quality System Regulation (QSR for medical devices), as specified in Title 21, Code of Federal Regulations CFR), Part 820, as follows:
1. Failure to review and evaluate complaints in a timely manner, as required by 21 CFR 820.198(a)(1). Our investigator found eight complaints that have not been completed and closed. Five of the complaints, which only had the customer information and part number completed on the Customer Complaint Records (CCRs), were identified as [redacted] (no date), [redacted] (received 2/15/05), [redacted] (received 2/25/05), [redacted] (received 3/24/05),and [redacted] (received 7/29/05). Three complaints had information completed on the CCRs or on similar forms, but there was no closing date or signature. These three complaints were identified as [redacted] (received 11/30/04), [redacted] (received 2/18/05), and [redacted] (received 4/21/05). Your response indicated that these complaints had been closed prior to the inspection. The only documents regarding complaints that you provided to our investigator during the inspection were CCRs. These CCRs were not closed, and some of them lacked any specific information about the complaint. Your response did not address why these records were not closed, and how you plan to correct this problem. Furthermore, you presented data in your response to show each of these complaints had been closed, but you provided no documentation with your response.
2. Failure to analyze 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 non-conforming product, or other quality problems, as required by 21 CFR 820.100(a)(1). During your quality audit schedules for 2003 and 2004, you cited the need for corrective actions in Regulatory Affairs, Engineering, Manufacturing, Purchasing, Customer Service, Shipping/Receiving, and Service-Repair. You failed to consistently document these corrective actions as completed or closed. Furthermore, your quality audit procedures and corrective and preventive action (CAPA) procedures do not indicate under what conditions a corrective action is raised to the CAPA level. In your response, you mention that audit findings that escalate to CAPA status will be managed to closure in accordance with the CAPA procedure, QPM [redacted] FDA collected a copy of QPM [redacted] during the inspection, and it does not make reference to the Quality Audit Procedures or CAPA procedures. In addition, you did not document in your response what corrective actions you have taken.
3. Failure to identify the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems, as required by 21 CFR Part 820.100(a)(3). Specifically, your investigations on three CAPA Requests, CAPA [redacted] (dated 3/8/04), CAPA [redacted](dated 5/26/04), and CAPA [redacted] (dated 12/13/04), were inadequate because you failed to document the analysis of the scope of the identified problem to include whether multiple components, devices, or lots were affected by the problems. In your response, you stated that these actions did not contain complete documentation, but the logic used at the time was evident and sufficient. Your response was not clear on how you came to this conclusion. As a result of this observation, you have revised several of your procedures, but you did not provide these documents for our review.
4. Failure to verify or, where appropriate, validate and document changes made to a specification, method, process, or procedure, as required by 21 CFR 820.70(b). Specifically, the Material Disposition Order (MDO) 1374, dated 9/28/04, addresses a specification change made for [redacted] due to a quality control test failure. The change was made to [redacted]. The MDO indicated that once the change had been initiated, the next production was to be resubmitted as a first article inspection. You have no documentation reporting this specification change was verified or validated, or that the next production run was submitted for a first article inspection. In your response you did not address how you will verify and validate a design change to a device.
5. Failure to maintain complaint files and implement the procedures for receiving, reviewing, and evaluating complaints, as required by 21 CFR 820.198(a). Specifically, you do not have documentation to show that six of your complaints on file have been fully investigated or that you have implemented the complaint handling procedures. These complaints are identified as follows:[redacted](no date), [redacted](no date), [redacted] (received 2/25/05), [redacted] (received 3/24/05), [redacted] (received 4/21/05), and [redacted](received 7/29/05). In your response, you did not address how you will make sure complaint handling procedures are effective and how you will make sure they are being followed. You also did not address how you will make sure open complaints are reviewed through your complaint handling procedures. Furthermore, you presented data in your response to show each of these complaints had been closed, but you provided no documentation with your response. You also stated that you made revisions to the Complaint record and associated procedures, but you did not send us these documents to review.
6. Failure to document corrective and preventive action activities, as required by 21 CFR 820.100(b). Specifically, you did not document the investigations to determine the cause of non-conformities, the actions needed to correct or prevent recurrence of nonconforming product and other quality problems, the verification or validation of corrective actions, and the implementation of corrective and preventive actions. Our investigator found eight CAPA investigations without documentation to show one or more of these requirements. The eight CAPAs identified are CAPA [redacted](dated 10/8/03), CAPA [redacted] (2/16/04), CAPA [redacted] (dated 4/6/04), CAPA [redacted](dated 5/26/04), CAPA [redacted] (dated 12/13/04), CAPA [redacted] (dated 1/17/05), CAPA [redacted] (dated 2/16/05), and CAPA [redacted] (dated 2/28/05). In your response, you provided data to show the status of these actions, but you provided no documentation for FDA to review.
This letter is not intended to be an all-inclusive list of violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of the violations and take prompt actions to correct the violations and to bring your products into compliance.
Federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, no premarket submissions for Class III devices to which QSR deficiencies are reasonably related will be cleared until the violations have been corrected. Also, no requests for Certificates for Products for Export will be approved until the violations related to the subject devices have been corrected.
You should take prompt action to correct these deviations. Failure to promptly correct these deviations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil penalties.
Please notify this office within 15 working days of receipt of this letter of the specific steps you have taken to correct the noted violations, including an explanation of each step being taken to identify and make corrections to any underlying system problems necessary to ensure that similar violations will not recur. Please include any and all documentation to show that adequate correction has been achieved. In the case of future corrections, an estimated date of completion, and documentation showing plans for correction should be included with your response to this letter.
Please send your reply to the Food and Drug Administration, Attention: Lisa M. Elrand, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021-4421. If you have questions regarding any issue in this letter, please contact Lisa M. Elrand at (425) 483-4913.
Charles M. Breen