Inspections, Compliance, Enforcement, and Criminal Investigations

Zoll Lifecor Corporation 9/23/14

  

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

Public Health Service
Food and Drug Administration
 PHILADELPHIA DISTRICT
900 U.S. Customhouse
2nd and Chestnut Streets
Philadelphia, PA 19106
Telephone: 215-597-4390 

 

WARNING LETTER
14-PHI-21
 
 
 
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
September 23, 2014
 
 
Mr. Marshal Linder, President and COO
Zoll Manufacturing Corporation
(formerly Zoll Lifecor Corporation)
121 Gamma Drive
Pittsburgh, PA 15238-2919
 
Dear Mr. Linder:
 
During an inspection of your firm located in Pittsburgh, Pennsylvania, on May 22, 2014 through June 20, 2014, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures medical devices, including the Class III medical device Life Vest. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are defined as 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, processing, packing, 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 (CFR), Part 820.
 
We received a response, dated July 14, 2014, 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 document results for corrective and preventive actions, as required by 21 CFR 820.100(b). Specifically,
 
a.    No corrective and preventive actions activities have been documented, as a result of high noise artifact and/or vibration causing the Life Vest device to inappropriately deliver shock treatments to patients. For example, (b)(4) complaints were observed in which noise artifact and/or vibration resulted in inappropriate shock treatments being delivered to patients.
 
The adequacy of your responses will be verified during our next scheduled inspection.
 
b.    No corrective and preventive action activities have been documented regarding the use of the Life Vest device in patients with cognitive and/or physical limitations. For example, (b)(4) complaints were observed in which physical and/or cognitive disabilities limited the user from interacting with the device as intended.
 
The adequacy of your responses will be verified during our next scheduled inspection.
 
c.    No corrective and preventive action activities have been documented regarding bystander interference with the device. For example, numerous complaints document that bystanders are interacting with the device, during cardiac events of patients, preventing treatment to be delivered. 
 
The adequacy of your responses will be verified during our next scheduled inspection.
 
2.    Failure to review, evaluate, and investigate complaints by a designated unit, as required by 21 CFR 820.198(a). Specifically,
 
(b)(4) complaints (b)(4) that reasonably suggest that Life Vest, model #4000, may have caused or contributed to a death or serious injury, were not thoroughly investigated and/or evaluated by the firm’s Regulatory Affairs Office.
 
We have reviewed your response, dated July 14, 2014, and have determined that your response is inadequate in that review of (b)(4) fails to include (b)(4). Additionally, evidence for the effective implementation of revised (b)(4), has not been provided for review. Furthermore, your response is silent as to submitting retroactive MDRs.
 
The adequacy of your response, dated August 22, 2014, will be verified during our next scheduled inspection.
 
3.    Failure to adequately establish procedures for design validation, as required by 21 CFR 820.30(g). Specifically,
 
a.    The device was not adequately validated under actual or simulated use conditions to ensure that it conforms to defined user needs and intended uses. For example, approximately half of all treatments delivered to patients are inappropriate shocks, as
evidenced by (b)(4) complaints, in which noise artifact and/or vibration were caused by various daily activities.  
 
The adequacy of your responses will be verified during our next scheduled inspection.
 
b.    The risk analysis for the device is inadequate, in that it does not contain any warnings or contraindications against lifestyle activities causing high noise artifact and/or vibration. 
 
The adequacy of your responses will be verified during our next scheduled inspection.
 
c.    The risk analysis for the device is inadequate, in that it does not consider the use of the device in patients with cognitive and/or physical limitations. For example, numerous complaints were observed where the device was supplied to patients, even though they could not interact with the device as intended. (b)(4) complaints document that these patients did not understand or know how to properly operate the device, due to their physical and/or cognitive disabilities.
 
The adequacy of your responses will be verified during our next scheduled inspection.
 
4.    Failure of management with executive responsibility to review the suitability and effectiveness of the quality system at defined intervals, and with sufficient frequency, according to established procedures to ensure that the quality system satisfies the requirements of 21 CFR 820 and the manufacturer’s established quality policy and objectives, as required by 21 CFR 820.20(c).
 
For example, there is no documented evidence showing that your firm’s executive management attended all (b)(4) management review meetings during 2013 and 2014.
 
The adequacy of your responses will be verified during our next scheduled inspection.
 
Our inspection also revealed that the LifeVest Wearable Defibrillator is misbranded under Section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information regarding the devices that is required by or under Section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 - Medical Device Reporting. Significant deviations include, but are not limited to: 
 
5.    Failure to report to us no later than 30 calendar days after the day that your firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that your firm markets may have caused or contributed to a death or serious injury, as required by 21 CFR 803.50(a)(1).

For example, (b)(4), references an event where a patient fell and broke her wrist after one of the shocks. The event describes a reportable serious injury. MDR (b)(4) was received by the FDA after the 30 calendar day timeframe.
 
We reviewed your firm’s response, dated August 22, 2014, and conclude that it appears to be adequate. Your firm submitted a revised procedure titled (b)(4), that (b)(4) for (b)(4) 
 
6.    Failure to report to us no later than 30 calendar days after the day that your firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that your firm markets would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur, as required by 21 CFR 803.50(a)(2).
 
For example, the information included for (b)(4) reference a malfunction of your firm’s device that meets the definition of an MDR reportable event. The MDRs were not received by the FDA within the 30 calendar day timeframe. 
 
We reviewed your firm’s response to the FDA 483, dated July 14, 2014, and conclude that it appears to be adequate. Your firm stated that it will retrain personnel and automate and validate its process.
 
7.    Failure to develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17. 
 
After reviewing your firm’s MDR procedure titled (b)(4), the following issues were noted:
 
a.    (b)(4) does not establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements. 
 
For example, the procedure omits the definitions of the terms “become aware,” “caused or contributed,” and “malfunction,” found in 21 CFR Part 803.3 and the definition for the term “reasonably suggests”, found in 803.20(c)(1). The exclusion of the definitions for these terms from the procedure may lead your firm to make an incorrect reportability decision when evaluating a complaint that may meet the criteria for reporting under 21 CFR 803.50(a).
 
b.    (b)(4) does not establish internal systems that provide for timely transmission of complete medical device reports. Specifically, the following is not addressed:
 
i.    Instructions for how to obtain and complete the FDA 3500A form.
 
c.    (b)(4) does not describe how your firm will address documentation and record-keeping requirements, including:
 
i.    Documentation of adverse event related information maintained as MDR event files.
 
The eMDR Final Rule requiring manufacturers and importers to submit electronic Medical Device Reports (eMDRs) to FDA was published on February 13, 2014. The requirements of this final rule will take effect on August 14, 2015. If your firm is not currently submitting reports electronically, we encourage you to visit the following web link for additional information about the electronic reporting requirements:
 
 
If your firm wishes to discuss MDR reportability criteria or to schedule further communications, it may contact the Reportability Review Team by email at: ReportabilityReviewTeam@fda.hhs.gov
 
Your firm 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 FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, 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 violations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates for 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) business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as 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 actions you have 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 these activities will be completed. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.
 
Your written response should be sent to Ms. Robin M. Rivers, Compliance Officer, U.S. Food and Drug Administration, 900 U.S. Customhouse, 200 Chestnut Street, Philadelphia, Pennsylvania 19106. If you have any questions about this letter, please contact Ms. Rivers at (215)717-3076 or e-mail at robin.rivers@fda.hhs.gov.
 
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 Inspection 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 action to correct the violations and bring the products into compliance.
 
Sincerely,
/S/ 
Anne E. Johnson
Acting District Director
Philadelphia District Office
 
 
cc: Pennsylvania State Department of Health
     132 Kline Plaza, Suite A
      Harrisburg, PA 17104
      Attention: Director, Division of Primary Care and Home Health Services

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