Inspections, Compliance, Enforcement, and Criminal Investigations

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1 Page 1 of 7 Inspections, Compliance, Enforcement, and Criminal Investigations Hammill Manufacturing Company 1/06/09 Department of Health and Human Services Public Health Service Food and Drug Administration Cincinnati District Office Central Region 6751 Steger Drive Cincinnati, OH Telephone: (513) FAX: (513) January 6, 2009 WARNING LETTER VIA FEDERAL EXPRESS CIN John E. Hammill Jr. President Hammill Manufacturing Company 360 Tomahawk Drive Maumee, OH Dear Mr. Hammill: During an inspection of your firm located in Maumee, Ohio, on September 4 through November 10, 2008, an investigator from the United States Food and Drug Administration (FDA) determined that your firm contract manufactures implantable prosthetics, such as tibias, hips, shoulders, bone screws, and spinal systems, as well as surgical instruments. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body.

2 Page 2 of 7 This 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, their manufacturing, packing, storage, or installation are not in conformance with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (C.F.R.), Part 820. We received your response, dated December 5, 2008, to our investigator's observations noted on the Form FDA 483, List of Inspectional Observations that was issued to you. We address your response below, as it relates to each of the noted violations. Those violations include, but are not limited to, the following: 1. Failure to analyze and trend nonconformances, complaints, and other sources of quality data to identify existing and potential causes of nonconforming products, or other quality problems, as required by 21 C.F.R (a)(1). For example: A review of your customer returns database from September 30, 2007, to October 1, 2008, revealed that of the 209,275 devices shipped during this time period, 15,444 devices were returned, a 7.4% return rate. You have not analyzed and trended this information to identify existing and potential causes of nonconforming products. A review of your in-process Non-Conforming Material Report database from September 30, 2007, to October 1, 2008, revealed 5,531 in-process nonconformances. You have not analyzed and trended these nonconformances to identify existing and potential causes of nonconforming products. We have reviewed your response, which states that you revised your Corrective and Preventive Action (CAPA) procedure and developed a new Data Analysis procedure for trending nonconformances and other quality data. We cannot determine whether this response is adequate without documentation. Please provide an example of your monthly trend data and copies of any CAPAs that you generated as a result of your review of this trending. 2. Failure of your CAPA procedure to address the analyses of quality data to identify existing and potential causes of nonconforming products and other quality problems, as required by 21 C.F.R (a)(1). For example, your CAPA procedure does not describe what quality data will be trended, how and how often this data will be trended and analyzed, and what statistical methodology will be employed to detect recurring quality problems. We have reviewed your response, which states that you developed a

3 Page 3 of 7 new Data Analysis procedure for trending nonconformances and other quality data and are trending this data monthly. We cannot determine whether this response is adequate without documentation. Please provide an example of your monthly trend data and copies of any CAPAs that you generated as a result of your review of this trending. 3. Failure to document, evaluate and investigate nonconforming product, as required by 21 C.F.R (a). For example: Of the 43 in-process nonconformances reviewed by our investigator, none had a documented failure investigation. Twenty-four of these 43 in-process nonconformances were not entered into your Non-Conforming Material Report database. Further, not all low quantity nonconformities (1 to 3) and those discovered at in-process checks are recorded on a Nonconforming Material Report Form. We have reviewed your response, which states that you revised your Control of Nonconforming Product procedure to more thoroughly identify and evaluate the root cause of nonconformances, and that you implemented this procedure on December 5, We have concluded that your response is inadequate because it does not address if all of the nonconformance information has been entered into your Non- Conforming Material Report database. Please provide examples of completed nonconformance forms and a copy of the records showing the training of your production employees on this revised procedure. 4. Failure to evaluate and investigate complaints involving the possible failure of a device to meet its specifications, as required by 21 C.F.R (a). For example, our investigator's review of thirteen complaints where product was returned revealed there were no documented failure investigations into the cause of these possible failures. We have reviewed your response, which states that you revised'your Control of Nonconforming Product procedure to include customer returns, so these returns will be evaluated and the root cause of nonconformances will be determined. We cannot determine whether this response is adequate without documentation. Please provide examples of nonconformance forms that have been completed as a result of customer complaints and/or returns. 5. Failure to document all CAPA activities, including failure investigations, actions needed to correct or prevent the reoccurrence of nonconforming product and other quality problems, verification or validation of corrective actions, implementation of corrective and

4 Page 4 of 7 preventive actions, and dissemination of information about quality problems or nonconforming products to responsible parties, as required by 21 C.F.R For example, your firm performed several failure investigations and took a corrective action outside of your CAPA system for the repeated returns of the polyaxial screws due to coaxial failures. Further, the corrective action was not verified and/or validated. We have reviewed your response and have concluded that it is inadequate because it does not assure that this nonconformance and the corrective action taken has been documented in your CAPA system. It also does not address your nonconformances and returns for the past year to determine if other failure investigations and corrective actions need to be documented in your CAPA system. 6. Failure to establish and maintain an adequate organizational structure to assure that quality system requirements are fully met, as required by 21 C.F.R (b). For example, your Quality Assurance Department consists of one individual, the Quality Manager, who is responsible for implementation of your CAPA system, quality audits, document control, training, developing procedures, conducting process validations, and all other aspects of your quality system for both medical and non-medical products. During the inspection your quality manager stated that he lacked sufficient time and resources to complete many of the Quality System requirements. Additionally, you stated that your quality system has not kept pace with the growth of your firm's business. We have reviewed your response, which states that you created a CAPA Coordinator position to manage and coordinate all aspects of the CAPA system. We cannot determine whether this response is adequate without documentation. Please provide a copy of this person's Curriculum Vitae and any documentation that demonstrates he or she has been trained in the Quality System Regulations. 7. Failure to validate a process whose results cannot be fully verified by subsequent inspection and test, and approve the validation according to established procedures, as required by 21 C.F.R (a). For example, you have not validated the static ultrasonic cleaning and passivation process, or the tumbling, cleaning and passivation process, nor have you validated the following machines used in the manufacture of medical devices: CNC (b)(4) machine, CNC grinding machine, CNC (b)(4) machine, CNC turning machine, CNC milling machine, robotic polishing machine, and (b)(4) machine. We have reviewed your response, which lists several other manufacturing processes (for example, your CNC processes and polishing) that you state do not need validation because you perform in-

5 Page 5 of 7 process and final inspection/tests. We have concluded that your response is inadequate because you are not testing every device to assure it meets specifications, and the results are not fully verified. All of these processes must be validated to ensure the specifications are consistently met or you must test all devices. Your response also states that you will perform process validation for the ultrasonic cleaning and passivation process, the tumbling ultrasonic cleaning and passivation process, and the laser markings process. We cannot determine whether this response is adequate without documentation. Please provide a copy of the validation protocols and final reports, when available, for each of these processes. 8. Failure to maintain Device Master Records (DMRs) that include, or refer to the location of, component specifications and production and process specifications for each medical device, as required by 21 C.F.R (a) and (b). 9. Failure to establish process control procedures for the laser etching process used to label and identify devices, as required by 21 C.F.R (a)(1). We have reviewed your response, which states that you have created Work Instruction WI-27 for this process. We cannot determine whether this response is adequate without documentation. Please provide a copy of this procedure and an example of a device history record that shows that the laser marking has been documented. 10. Failure of the designated individual to review for adequacy and approve in-process and final inspection forms and work instructions, as required by 21 C.F.R (a). 11. Failure to maintain records of ch anges to documents, as required by 21 C.F.R (b). 12. Failure of your quality audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system, as required by 21 C.F.R

6 Page 6 of 7 We have reviewed your response and have concluded that it is inadequate because your Internal Quality Audits procedure does not assure your firm's compliance with the Quality System Requirements of the Code of Federal Regulations. Please provide a copy of the checklist showing what is covered during the audit and your audit schedule. 13. Failure of management with executive responsibility to participate in management reviews, as required by 21 C.F.R (c). You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, 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, premarket approval applications for Class III devices to which the Quality System regulation deviations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected. Please notify this office in writing within fifteen working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violation(s), from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. Ifcorrective action cannot be completed within fifteen working days, state the reason for the delay and the time within which the corrections will be completed. Your response should be sent to Ms. Gina Brackett, Compliance Officer, Food and Drug Administration, 6751 Steger Drive, Cincinnati, Ohio If you have any questions concerning the content of this letter, please contact Ms. Brackett at (513) , extension 167, or you may forward a facsimile to her at (513) Finally, you should know that this letter is not intended to be an all-inclusive list of the 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, 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.

7 Page 7 of 7 Sincerely, /S/ Teresa C. Thompson District Director Cincinnati District