Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
300 River Place
Detroit, Ml 48207
July 2, 2014
Daniel J. Bowen, Principle of Dempsey Ventures, LLC.
2710 Northridge Dr. Northwest
Grand Rapids, Michigan 49544-9112
Dear Mr. Bowen:
During an inspection of your firm located in Grand Rapids, Michigan on May 2, 2014 through June 4, 2014, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures a variety of Ventlab Manual Resuscitation Bags. 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 any 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 Debbie Daly, Vice President of RA/QA dated June 24, 2014 concerning our investigators observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, 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 21CFR 820.100(a).
a. For example, your firm’s Standard Operating Procedure (SOP) No. 1.001 Corrective and Preventive Action Procedure (Rev. 9; 3/6/13) states under section 6.1 (Quality Data Sources), "(b)(4).'' However, from February 2012 through May 2013, your firm received 47 complaints related to duckbill nonconformities of your resuscitation bags and on April 17, 2013, you opened CAPA 13-011 and determined the root cause of the duckbill nonconformities in the resuscitator bags to be due to not following the duckbill valve washing/drying process. However, duckbill valve complaints received after opening CAPA 13-011 were not fully analyzed to identify other potential causes of the nonconformances. For example: Complaints received from June 2013 through March 2014, include Complaint numbers 818, 847, 858, 866, 873, 877 and 906, involved complaints regarding the duckbill sticking; however, many of these units were washed and dried, unlike the complaints that lead to the initiation of CAPA 13-011.
SOP No. 1.001 Corrective and Preventive Action Procedure (Rev. 9; 3/6/13) states under section 6.2.6 (Follow-Up of CAPA Effectiveness), "(b)(4)..” And “(b)(4).." However, CAPA 13-011 was determined to be effective and closed on September 27, 2013 however, no data was reviewed prior to its closure to evaluate the effectiveness of the corrective actions.
Your firm’s response is inadequate as it does not include your plan for ensuring all previous complaints relating to closed CAPAs were fully analyzed to identify other potential causes of the nonconformances and that data was reviewed prior to its closure to evaluate the effectiveness of the corrective actions. Additionally, your plan for managing CAPAs going forward does not include how you will ensure that each quality data source related to a CAPA is fully analyzed to identify the cause of the nonconformity.
2. Failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). SOP No. 1.004 Complaint Processing Procedure (Rev. 13; Effective 4/26/13) states “(b)(4)."... and further lists 13 questions that must be answered for each complaint. However, between June 3, 2013 and March 3, 2014, your firm received 38 complaints related to stuck duckbill valves in resuscitator bags and of those 38 complaint records, 34 do not contain the required information and therefore prohibit the conduction of a thorough investigation as required by your procedure. Additionally, your firm’s failure to obtain detailed information about each complaint does not allow for the prompt review, evaluation and investigation of any complaint that represents an event which must be reported to FDA under part 803, as required by 21 CFR 820.198(d); and the failure to adequately evaluate complaints to determine whether the complaint represents an event which must be reported under part 803 resulted in the failure of your firm to report Complaint 791. For example, complaint 791 involved a failure of the diaphragm of your firm’s V-Care Infant Resuscitator to “open when pressed” which resulted in a delay in treatment and necessitated medical intervention to preclude permanent impairment or death.
Your firm’s response is inadequate as it does not include your plan for ensuring detailed information was obtained for past complaints and evaluations, investigations and reporting to FDA under 21 CFR 803 were conducted as appropriate. However, your plan for management of complaints in the future appears adequate.
3. Failure to establish and maintain procedures to ensure that all purchased or otherwise received products or services conform to specified requirements, as required by 21 CFR 820.50(a) and to establish and maintain an agreement that suppliers agree to notify your firm of changes in the product they provide so your firm may determine whether the changes may affect the quality of the finished product, as required by 21 CFR 820.50 (b). For example, from February 1, 2012 through May 2013, your firm received and utilized for manufacturing, patient valves containing duckbill valves that did not conform to the specified requirements of being washed, dried and lubricated and these changes in the manufacturing process were not communicated to your firm by your supplier.
As part of CAP A 13-011, on May 4, 2013, you identified that failing to follow the washing and drying process can cause the duckbill valves to stick and the drying acts as a secondary cure for the silicone material. To date, at least five complaints (Numbers 858, 866, 873, 877, and 906) describing stuck duckbill valves have been received relating to eight lot numbers (200221, 200589,200173, 99301, 101304, 98820, 85521 and 104120) of finished resuscitator bags in which the duckbill valve component were washed and dried.
In May 2014, these actions led to a Class 1 Recall of a variety of your firm’s resuscitation bags (RES 68242). Your firm has manufactured and sold (b)(4) finished resuscitator bags between May 4, 2013 and May 2, 2014.
The adequacy of your firm’s response cannot be determined at this time as your corrective action has not been completed.
4. Failure to establish and maintain procedures for risk analysis, as required by 21 CFR 820.30(g). For example, your firm’s Risk Management Plan for manual resuscitators has not been reviewed and/or updated to take into account information relating to the potential hazard of device aging and its potential adverse impact on your firm’s resuscitator valves, despite being aware of the following:
A Risk Management Plan was last completed for your firm’s manual resuscitators on August 9, 2013. It identifies a material degradation risk of “Bag performance decreased due to aging over time." and identifies the probability of occurrence as “Remote Refer to shelf life justification". The shelf life justification (dated 8/8/13) states, "Product performance is monitored over the life of the device and any malfunction or deterioration in the characteristics and/or performance of the device is reported as needed and fed back into the risk analysis and clinical evaluation process."
ET13-006 (dated 5/4/13) completed as part of CAPA 13-011 (created due to 47 complaints regarding sticking duckbill valves) states that your supplier “found (b)(4) of (b)(4) spacer duckbill valves that were slightly sticking together. Not all of the (b)(4) samples were entirely stuck together, but some portion of the valve was slightly stuck together. The spacer valve product was more than 2 years old, but the team at the ... facility has not seen this condition before.”
FDA investigators discovered that spacer valves and duckbill valves are manufactured with a similar silicone material.
Complaint 877 (dated 11/4/13) is regarding stuck duckbill valves in finished resuscitator bags. The approximate time from the U.S. assembly date of the finished device to the complaint date is 544 days for lot 101304, 643 days for lot 99301, 675 days for lot 98820, and 1,454 days for lot 85521.
The adequacy of your firm’s response cannot be determined at this time as your corrective action has not been completed.
5. Failure to establish and maintain procedures to control product that does not conform to specified requirements as required by 21 CFR 820.90(a).
For example, as part of CAPA 13-011, on May 4, 2013, you determined that the failure to follow the wash and dry process was the root cause of stuck duckbill valves in the patient valve sub-assemblies; however, between May 4, 2013, and May 23, 2013, you received two shipments of patient valves that did not all receive the wash and dry process. One of these shipments, Ventlab-US lot 21585, consisting of (b)(4) patient valves, was not identified as non-conforming product and was subsequently utilized in the manufacture of resuscitator bags (10 bags with product code VN2002MCP and lot 200492) without the Material Review Board making a disposition of these nonconforming sub-assemblies as required by your procedure SOP No. 3.002 Control of Nonconforming Material (Rev. 10; Effective 11/6/12) that states “(b)(4).”
Your firm’s response is inadequate as it does not include your plan for ensuring your procedure SOP No. 3.002 Control of Nonconforming Material (Rev. 10; Effective 11/6/12) is followed or for how you will designate and isolate nonconforming product.
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 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, 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 (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. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.
Your firm’s response should be sent to: Food and Drug Administration-Detroit District Office 300 River Place, Suite 5900 Detroit, MI 48207. Refer to CMS# 43318 when replying.If you have any questions about the contents of this letter, please contact: CDR Kimberly Martin at (317) 226-6500 ext. 116.
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.
Art O. Czabaniuk
Acting District Director
Detroit District Office