Inspections, Compliance, Enforcement, and Criminal Investigations
Sanmina-SCI AB 4/11/14
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|10903 New Hampshire Avenue|
Silver Spring, MD 20993
April 11, 2014
VIA UNITED PARCEL SERVICE
Mr. Tim McGinnis,
Vice President RA/QA
Sanmina SCI AB
Sjalevad, Ornskoldsvik SE891 23 Sweden
Dear Mr. McGinnis:
During an inspection of your firm located in Ornskoldsvik, Sweden on December 9, 2013 through December 12, 2013, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Afinion AS 100 Analyzer for Axis-Shield (Norway). 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 to affect the structure or function of the body.
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 manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.
We received a response from Mr. Tim McGinnis, Vice President of RA/QAdated December 20, 2013 concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to your firm. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
1. Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). For example, your firm did not identify actions needed to correct and prevent recurrence of nonconforming product and other quality problems. In addition, your firm failed to verify or validate corrective actions implemented to ensure that such actions are effective and do not adversely affect the finished device. Specifically:
i. Corrective Action M3292, opened on 6/26/2012, did not have a corrective action identified and did not document verification activities completed to demonstrate that the action was effective and would not adversely affect the finished devices; the CAPA was closed 12/14/2012. The CAPA was opened because the Return Material Authorization (RMA) Metric Performance had gone from (b)(4). Your firm’s document, Sop-3-MD5001-A Management Responsibility, Document No. E52-1200-100-008, Revision AC, dated 2013-10-23, indicates that the quality objective for this plant is to obtain an RMA (% of Net Sales) of (b)(4)%. The plant obtained RMA% values (b)(4) and (b)(4) for (b)(4) and (b)(4) respectively. The CAPA was closed on 12/14/2012 without a corrective action identified or verification of effectiveness of the action.
ii. Corrective Action M3766, opened on 11/21/2012, did not have verification activities performed. Your firm implemented (b)(4) corrective actions for the (b)(4) issues affecting (b)(4) Afinion AS 100 units and sent a report to its’ customer for approval without performing verification activities for these corrective actions implemented.
We reviewed your firm’s response and conclude that it is not adequate. For Corrective Action M3292, you planned to add an effective corrective action and perform verification activities. To ensure there are no other similar omissions, your firm also planned to review all CAPA's for the last 3 years by April 2014. For Corrective Action M3766, your firm planned to perform an adequate verification. In addition, your firm planned to reach an agreement with the customer to implement a CAPA matrix to ensure alignment on whether a returned product warrants a corrective action from your firm.
These responses are not adequate because your firm did not provide documentation or evidence of the implementation of corrections and corrective action to either CAPA case as stated above or a timeline indicating when these actions would be completed. In addition, your firm did not provide evidence that identified the cause of the omission of corrective action and verification activities for the CAPAs and implement the actions including revising protocols or instructions where necessary to ensure such errors will not occur in the future. Your firm did not provide justification for reviewing only the last 3 years’ of CAPAs and evidence that you considered a systemic corrective action.
2. Failure to ensure that when the results of a process cannot be fully verified by subsequent inspection and test that the process shall be validated with a high degree of assurance and approved according to established procedure, as required by 21 CFR 820.75(a). For example, process validation was not adequately performed on the (b)(4) process. Specifically, the performance qualification (PQ) was not performed for the validation of the (b)(4) system used in conjunction with the (b)(4).
The adequacy of your firm’s response cannot be determined at this time. Although your firm planned to revalidate (b)(4) to include the PQ for the (b)(4) and review other related processes and documents to ensure there are no further inaccuracies or omissions by January 31, 2014, your firm did not include documentation or evidence of the corrections and corrective actions other than submitting one page of the revised Plant Master Validation Plan to specify that PQ would be required for (b)(4) and (b)(4). In addition, your firm did not provide evidence that you considered a systemic corrective action to include a retrospective review of all processes requiring validation to ensure they were validated as required.
U.S. federal agencies may be advised of the issuance of 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 business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, including an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective action (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Please provide a translation of documentation not in English to facilitate our review.
Your firm’s response should be sent to: Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, Field Operations Branch, White Oak Building 66, Rm 2622, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case #423189 when replying. If you have any questions about the contents of this letter, please contact: James L. Woods, at 301-796-6225 or fax 301-847-8513.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.
Office of In Vitro Diagnostics and
Center for Devices and