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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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CareFusion Corp dba Productos Urologos De Mexico S.A. De C.V. 5/7/12


Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 10903 New Hampshire Avenue
Silver Spring, MD 20993

MAY 7, 2012




Mr. Rogelio Gutierrez
Director of Manufacturing Operations
CareFusion Corp dba Productos Urologos De Mexico S.A. De C.V.
Cerrada Via De La Produccion #85
Parque Industrial Mexicali III
Mexicali B.C., Mexico 21397

Dear Mr. Gutierrez:

During an inspection of your firm located in Mexicali B.C., Mexico, on January 23, 2012, through January 26, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Airlife Oxygen Mask, Air Life Misty Max 10 Nebulizers, and Airlife Nasal Oxygen Cannula. 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 Joe Hutson, Vice-President of Quality and Regulatory Affairs, dated February 13, 2012, concerning our investigator's observations noted on the Form FDA 483 (FDA 483), List of lnspectional 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 adequate procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a).

For example: (b)(4) No. MX-1001-000, with issue date December 8, 2010, requires that only two extensions be permitted per corrective action. However, CAPA file TS-10-002-C had a third extension approved on February 28, 2011, and a fourth extension approved on July 1, 2011, for corrective action #4, which required the evaluation of (b)(4). After an increase in complaints and Medical Device Reports, CAPA file TS-11-011-C was initiated on August 8, 2011, to investigate (b)(4). Your firm closed the initial CAPA TS-10-002, indicating that it was completed on October 5, 2011. Corrective action #4 from CAPA file TS-10-002-C was transferred to CAPA file TS-11-011-C but the corrective action, the evaluation of a change in (b)(4) for the Temp Probe Port 65-2734 from (b)(4) had not been conducted at that time.

The response dated February 13, 2012, is not adequate. Your firm has decided that the CareFusion manufacturing facility located in Mexicali, Mexico, will implement the global CAPA policy QPL-8.5.28 Corrective and Preventive Action (CAPA) Process, dated February 10, 2012. Your firm did not indicate if it had determined that the fifteen open CAPAs are in accordance with the new global CAPA policy QPL-8.5.28. Your firm did not provide evidence of implementation of the new global CAPA policy QPL-8.5.28 or provide evidence that the risk determination, containment and corrective and preventive action effectiveness verification/validation associated with CAPA TS-11-011-C was conducted. Additionally, your firm has not provided evidence that it considered systemic corrective actions including review and determination if all CAPAs have been properly closed in accordance with your firm's CAPA procedure.

2. Failure to adequately ensure ,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 with documentation of the validation activities and results, including the date and signature of the individuals approving the validation and, where appropriate, the major equipment validated, as required by 21 CFR 820.75(a). For example:

a. Your firm's process validation procedure titled, (b)(4) Document MX-0710-000, issued on November 17, 2011 , does not ensure that all validation activities and their results are documented and retained for Operational/Performance Qualifications. MX-10-209, (b)(4) dated June 14, 2012, and MX-09-178, (b)(4) dated July 14, 2009, were both reviewed and did not have documentation of the Operational Qualification runs that were conducted. In the file, there was no documentation of the actual equipment parameters set for each run, identification of the operator conducting the runs, or the dates of the runs.

b. An Operational/Performance Qualification, MX-10-209, (b)(4) dated June 14, 2012, did not meet the predefined acceptance criteria outlined in the protocol. The testing conducted was subsequently changed and the acceptance criteria were modified to enable the test results to pass. No documentation of the protocol or protocol deviations approving these changes was available prior to the initiation of the changes.

The adequacy of your firm's response cannot be determined at this time because evidence of implementation of the remedial corrective action was not submitted for review. Your firm re-performed the two process validations for MX-10-209 and MX-09-178. Your firm stated that the validation was successfully completed on February 13, 2012, without any modifications required to pass validation and that therefore the previous production is acceptable. Additionally, your firm revised the local procedure FSP MX-0710-000, (b)(4) on February 9, 2012, to require documentation for all Operational Qualifications, Performance Qualification and employee training. The new procedure included clarification of process validation acceptance criteria and requirements for acceptance criteria deviations. Your firm also plans to conduct a 2-year retrospective review as a remedial corrective action to re-perform 35 process validations in accordance with the requirements established in FSP MX-0710-000, (b)(4) February 9, 2012. The 2 year retrospective review was due by April 19, 2012.

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 (including any systemic corrective actions) 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 2609, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case #287859 when replying. If you have any questions about the contents of this letter, please contact: Charles Cathlin at (301) 796-5548 or via facsimile at (301) 847-8128.

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 lnspectional 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.

Sincerely yours,


Seven D. Silverman
Office of Compliance
Center for Devices and
Radiological Health