| Public Health Service Food and Drug Administration |
| New England District One Montvale Avenue Stoneham, Massachusetts 02180 (781) 596-7700 FAX: (781) 587-7500 |
Department of Health and Human ServicesWARNING LETTER
NWE -16-11W
VIA UPS Next Day Air
April 22, 2011
Mr. Richard Packer
Chief Executive Officer
ZOLL Medical Corporation
269 Mill Road
Chelmsford, MA 01824
Dear Mr. Packer:
During an inspection of your firm located in Chelmsford, MA on January 24 through March 18, 2011, investigator(s) from the United States Food and Drug Administration (FDA) determined that your firm manufactures cardiac resuscitation products, including the Zoll Automated External Defibrillators (AED) and E Series, defibrillators. 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.
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 (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (C.F.R.), Part 820. We received a response from Mr. Paul Dias, Vice President of Service, Quality and Regulatory Affairs, dated April 8, 2011 concerning our investigator’s observations noted on the Form FDA 483, List of Inspectional Observations that was issued to you. We address this response below, in relation to the noted violations in this letter. These violations include, but are not limited to, the following:
1. Failure to identify all actions needed to correct and prevent the recurrence of nonconforming product and other quality problems, as required by 21 CFR 820.100(a)(3).
CAPA 2009-026 was opened to address the failure to validate battery life cycle when used as intended in standby mode. The documented root cause states initial battery lifecycle validation, based on a period of battery life data and a calculation, did not account for the build up of a “high resistive layer (a.k.a. passivation)”. The CAPA fails to assess the impact of passivation as it relates to the calculation of expected battery lifecycle and no corrective actions were identified for re-calculation of expected battery life. Your firm has received 15 complaints from September 2009 through January 2011 of battery depletion prior to calculated 5 year battery lifecycle your firm relies on, however your firm has still not re-evaluated the calculation used.
Your firm submitted the “AED Battery Life Calculation” memo dated November 5, 2009 as Att. 2 in your FDA 483 response in support of the calculation used to determine battery life cycle. This response is inadequate because the memo does not provide the formula used in the calculation, reference the location of data which supports the calculation, or identify test methods or equipment used to obtain data. The memo also fails to address the impact of passivation on battery life or identify if it is considered in the calculation. Additionally, this memo was collected by our investigators as part of the CAPA 2009-26 file, however the file copy has a date of November 4, 2009.
Also submitted in your firm’s response to the FDA 483 as Att. 5 was a validation strategy “AED Plus Standby Battery Life Validation” document, which is not titled or dated. This memo identifies the formula used to calculate battery depletion. The value of 5 years is used in the calculation to determine total depletion. The memo relies on reference data measuring current consumption (b)(4). This response is inadequate because it assumes a 5 year lifecycle, is not supported by current data from a statistically valid sample, and the calculation fails to address the impact of passivation on premature battery capacity consumption.
Additionally, your firm failed to implement the corrective action identified in CAPA 2009-026 with an implementation date of 12/09/2009. Your firm failed to implement the AED Plus Post Market Life Cycle Test Plan as documented in a 01/25/11 memo to the CAPA file which states your firm failed to acquire the first set of test data at the one year time point.
We note this same plan is submitted as part of your response to the FDA 483 as Att. 4. This document was submitted without any supporting data. Your response indicates concurrent testing of product is part of your validation strategy for battery life cycle. We find this response is inadequate. We acknowledge your statement that your firm has “implemented a plan that simulates and monitors the battery performance within our product over the course of 5 years”. However your firm already identified this corrective action as part of CAPA 2009-026 and failed to implement it in 2009. The life cycle test plan collected by our investigators as part of CAPA 2009-026 has an initial release date of 10/27/09, while the copy submitted in your response has a preliminary date of 9/24/09, no release date, and the latest revision date of 04/04/11. Please provide a response which addresses your firm’s failure to implement corrective actions.
2. Failure to verify or validate a corrective and preventative action to ensure that such action is effective and does not adversely affect the finished device as required by 21 CFR 820.100(a)(4).
CAPA 2009-026 was opened to address the failure to validate battery life cycle when used as intended in standby mode. The first corrective action identified by your firm was revision of the “Design Verification and Validation Requirements” document (5002-0005 SOP) to include a lifecycle testing and verification requirement. This document was submitted with your response as Att. 3. Additional corrective actions identified include developing and implementing the lifecycle test plan required by your Design Verification and Validations Requirements SOP. The effectiveness check date documented in CAPA 2009-26 is 12/15/2014. This is inadequate to assure that corrective actions have been implemented and are effective. As explained in Warning Letter item 1, your firm developed a lifecycle test plan as required by your SOP but failed to implement the plan as documented in the 01/25/11 memo to the CAPA file.
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 (15) 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 violations, 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. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
With regard to your response to FDA 483 items 1.2 and 1.3 regarding defects found in the E Series Defibrillator. We acknowledge that your firm has engaged the services of a consultant to provide a complete a review of your software validation systems, conduct an onsite review of your processes, and provide recommendations for improvements and that you anticipate the completion of the onsite audit (b)(4). We also note that your firm has promised to initiate voluntary recall of the E Series, but as of the date of this letter you have failed to submit recall information to the district for the device with software (b)(4) as stated in your response.
Please direct your response or any questions you may have to Anthony P. Costello, Compliance Officer, Food and Drug Administration, One Montvale Avenue, 4th Floor, Stoneham, Massachusetts 02180. His telephone number is (781) 587-7492.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violation(s) 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 violation(s) and to bring your products into compliance.
Sincerely,
/s/
Amber G. Wardwell
Acting District Director
New England District
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