| Public Health Service Food and Drug Administration |
| Chicago District 550 West Jackson Blvd., 15th Floor Chicago, Illinois 60661 Telephone: 312-353-5863 |
Department of Health and Human Services
February 25, 2011
WARNING LETTER
CHI-06-11
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Carr Lane Quackenbush
President
Medela, Inc.
1101 Corporate Drive
McHenry, Illinois 60050
Dear Mr. Quackenbush:
During an inspection of your firm located in McHenry, Illinois from October 4, 2010 through November 1, 2010, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures breast pumps, breast pump kits, and pediatric feeding devices (breast milk storage products) for human use. 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.
The inspection revealed that these devices are adulterated within the meaning of Section 501(h) of the Federal Food, Drug, and Cosmetic Act (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 holding 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 from Carr Lane Quackenbush, President and Donald Alexander, Vice President Quality Management and Regulatory Affairs, dated November 22, 2010, concerning our investigator’s observations noted on the Form FDA 483, Inspectional Observations, that was issued to you. 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 adequately establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a).
For example:
a. Complaint remediation activities initiated in July of 2010 have identified (b)(4) complaints. Quality data contained within these complaints have not been analyzed to identify existing and potential causes of nonconforming product or other quality problems. Fourteen Pump in Style Advanced (PNSA) electric breast pump complaints document motors and transformers smoking or catching fire;
b. Actions needed to correct an in-process inventory of PNSA printed circuit boards (PCBs) identified as containing potential defects associated with (b)(4) (which could cause low vacuum, loss of vacuum, or the pump’s inability to power on) were not identified. After distribution of product manufactured from this inventory of PCBs, Return Material Authorization (RMA) returns for issues associated with this PCB increased from an average of (b)(4).
We reviewed your response and conclude that it is not adequate because while your firm initiated the (b)(4) project, which is meant to update and establish new CAPA and related procedures, and provided an action plan with a timeline to remedy the issues mentioned above, your firm failed to initiate a systemic corrective action to address the issues. Your firm failed to look at retroactive CAPAs, determine if new CAPAs would need to be opened, and evaluate related procedures and subsystems to determine if they also need to be addressed in a similar manner. In addition, your firm did not provide evidence of implementation of all of the planned actions.
2. Failure to adequately establish and maintain complaint files, including procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).
For example:
a. (b)(4) of a sample of (b)(4) Return Material Authorizations reviewed (b)(4) communicated alleged deficiencies related to quality, reliability, or performance of Pump in Style Advanced (PNSA) and Freestyle electric breast pumps. These communications were not recognized as complaints by your firm’s customer service representatives or servicing technicians nor documented as complaints on customer complaint/issue form (b)(4).
b. Complaint files do not document the complete nature and details of complaints or an explanation of the efforts made to ascertain the information. Complaint File Nos. (b)(4) document alleged pain and injury events yet do not document the patient outcome including whether medical intervention was necessary or your firm’s efforts to ascertain this information.
We reviewed your response and conclude that it is not adequate because while your firm initiated the (b)(4) project, which is meant to establish new Complaint Handling and Adverse Event Reporting procedures, and provided an action plan with a timeline to remedy the issues mentioned above, your firm failed to initiate a systemic corrective action to address the issues. Your firm failed to review all previous complaints and MDRs, determine the cause for why proper information is not being gathered for complaints, and evaluate related procedures and subsystems to determine if they also need to be addressed in a similar manner. In addition, your firm did not provide evidence of implementation of all of the planned actions.
3. Failure to adequately establish and maintain procedures for validating the device design, as required by 21 CFR 820.30(g).
For example, your firm’s risk assessment for the Pump and Save breast milk bags used with the Pump in Style Advanced (PNSA) pumps did not consider the effect of (b)(4) on the performance of the storage bags.
We reviewed your response and conclude that it is not adequate because while your firm initiated the (b)(4) project, which is meant to update the Risk Management program, conducted certain risk assessment studies, and provided an action plan with a timeline to remedy the issues mentioned above, the data did not support your firm’s conclusions as it did not adequately address all the concerns and was not gathered with any statistical rationale. Your firm also failed to initiate a systemic corrective action to address the issues. Your firm failed to review all aspects of the risk assessment process to determine if other components were lacking, review other risk assessments for similar short comings, and evaluate related procedures and subsystems to determine if they also needed to be addressed in a similar manner. In addition, your firm did not provide evidence of implementation of all of the planned actions.
4. Failure to adequately establish and maintain a design history file (DHF) for each type of device that contains or references the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of 21 CFR 820, as required by 21 CFR 820.30(j).
For example, the Pump in Style Advanced (PNSA) DHF did not contain or reference design input requirements, design outputs (including outputs essential to the proper functioning of the device and the device master record), or the results of design verification and design validation.
We reviewed your response and conclude that it is not adequate because while your firm initiated the (b)(4) project, which is meant to re-engineer both the Design Control Quality System and the Change Control Quality System by reviewing and updating necessary design procedures, expanding (b)(4) to include the observation from the FDA 483, and provided an action plan with a timeline to remedy the issues mentioned above, your firm failed to initiate a systemic corrective action to address the issues. Your firm failed to review all aspects of the design history file to determine if other components were lacking, review other device history files for similar short comings, and evaluate related procedures and subsystems to determine if they also needed to be addressed in a similar manner. In addition, your firm did not provide evidence of implementation of all of the planned actions.
5. Failure to adequately document acceptance activities, as required by 21 CFR 820.80(e).
For example, your firm conducts in-process testing “Vacuum Performance Testing – Double Pumping Vacuum requirements” on each Pump in Style Advanced (PNSA) electric breast pump to verify proper functionality. These in-process test results are not documented in the device history record (DHR).
We reviewed your response and conclude that it is not adequate because while your firm initiated the (b)(4) project, which is meant to re-engineer the Production and Process Control Quality system by April 2011, and indicated that each PNSA pump is now individually tested to fully verify the device is performing as intended and PNSA breast pump production will restart once the production line verification and validation activities are complete, your firm failed to assure that all test results are documented in the DHR. Your firm also failed to provide an actual timeline for completing the verification/validation testing. In addition, your firm failed to initiate a systemic corrective action to address the issues. Your firm failed to review all aspects of the DHR to determine if other required activities were also not documented, review other DHRs for similar short comings, and evaluate related procedures and subsystems to determine if they also needed to be addressed in a similar manner. Your firm also did not provide evidence of implementation of all of the planned actions.
6. Failure to adequately establish and maintain procedures to control all documents that are required by 21 CFR 820, as required by 21 CFR 820.40.
For example:
a. Visual aid instructions for the Pump in Style Advanced (PNSA) assembly process were in use without approval.
b. At the time the PNSA breast pump was first launched (August 2003), the functional testing performed for the pump included verification testing for both the stimulation and expression modes according to PNS OQM Checklist (b)(4) Functional Testing, dated 08/26/2003. All of the stimulation mode verification tests as well as the expression mode single pumping tests were removed from (b)(4) in December 2007. No Document Change/Release Order was generated to control this change as required by your firm’s Document Change Order (b)(4).
We reviewed your response and conclude that it is not adequate because while your firm initiated the (b)(4) project, which is meant to re-engineer the Labeling, Document and Change Control System, create a Device Master Record Index protocol, and create a Labeling protocol, and provided an action plan with a timeline to remedy the issues mentioned above, your firm failed to initiate a systemic corrective action to address the issues. Your firm failed to review all aspects of the document control procedures to determine if other components were lacking, evaluate all instructional aid to ensure they had all been approved and unapproved instructions had been adequately disposed, and evaluate related procedures and subsystems to determine if they also needed to be addressed in a similar manner. In addition, your firm did not provide evidence of implementation of all of the planned actions.
Our inspection also revealed that your electric breast pumps are misbranded under Section 502(t)(2) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 352(t)(2)], in that your firm failed or refused to furnish material or information respecting the device that is required by or under Section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 – Medical Device Reporting (MDR) regulation. Significant deviations include, but are not limited to, the following:
1. Failure to report to us no later than 30 calendar days after the day that you received or otherwise became aware of information, from any source, that reasonably suggests that a device you market may have caused or contributed to a death or serious injury, as required by 803.50(a)(1).
For example:
a. Complaint (b)(4) describes that the patient sought medical attention and was prescribed antibiotics and pain medication. Based on the lack of evidence indicating that treatment with a prescription antibiotic was not necessary to preclude permanent impairment of a body function or permanent damage to a body structure, the referenced complaint meets the definition of a serious injury.
b. Complaint (b)(4) describes a patient who was diagnosed with mastitis. Mastitis is an inflammation of the breast usually caused by a bacterial infection. Literature review indicates that “Mastitis will not go away without treatment.” Without additional information from you indicating that (1) the device did not cause or contribute to the mastitis, and/ or (2) that treatment is not necessary to preclude permanent impairment of a body function or permanent damage to a body structure, we conclude that complaint (b)(4) meets the definition of a serious injury.
We reviewed your response and conclude that it is not adequate because while your firm submitted MDRs for complaint (b)(4) and complaint (b)(4), your firm failed to correctly identify the event type in Block H.1 of the FDA Form 3500A. The event type listed in both MDRs is identified as “Other” when it should have been identified as “Serious Injury”. Your firm will need to submit a supplemental report for each MDR in order to correct this error.
2. Failure to report to us no later than 30 calendar days after the day that you received or otherwise became aware of information, from any source, that reasonably suggests that a device you market has malfunctioned and this device or similar device that you market would be likely to cause or contribute to a death or serious injury if the malfunction were to recur, as required by 803.50(a)(2).
For example, Complaint (b)(4) states that during use the device caught on fire and smoke came out the sides of the motor. Complaint (b)(4) describes that the (b)(4) caught on fire. The information in these complaints reasonably suggests that the reported malfunctions are likely to cause or contribute to a death or serious injury if they were to recur.
We reviewed your response and conclude that it is not adequate because your firm failed to submit malfunction MDRs for complaint (b)(4) and complaint (b)(4) which involved reports of fire.
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 violations 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) business days from the date you receive this letter of the specific steps you have taken to correct the noted violations, as well as an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions you have taken. If your planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of these activities. If corrections and/or corrective actions cannot be completed within 15 business days, state the reason for the delay and the time within which these activities will be completed. Your response should be comprehensive and address all violations included in this WL.
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 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. You should investigate and determine the causes of the violation(s), and take prompt actions to correct the violation(s) and to bring your products into compliance.
Your response should be sent to: Lorelei Jarrell, Compliance Officer, Food and Drug Administration, 550 W. Jackson Blvd., 15th Floor, Chicago, IL 60661. If you have any questions about the content of this letter, please contact Ms. Jarrell at 312-596-4216.
Sincerely,
/S/
Scott J. MacIntire
District Director
cc:
Mr. Donald Alexander
VP Quality Management & Regulatory Affairs
Medela, Inc.
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