Inspections, Compliance, Enforcement, and Criminal Investigations
Commed, Inc 7/30/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
July 30, 2012
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 12-26
Guy R. Bennett, President
10215 N.E. 41st Avenue
Vancouver, Washington 98686-5812
Dear Mr. Bennett:
During an inspection of your firm located in Vancouver, Washington, on March 26, 2012, through April 02, 2012, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures tracheostoma covers and stoma screens. 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 cGMP requirements of the Quality System regulation found under Title 21, Code of Federal Regulations (CFR), Part 820. These violations include, but are not limited to, the following:
1. Failure to establish and maintain adequate procedures for the identification, documentation, validation or, where appropriate, verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(i).
For example, your firm’s Change Controls procedure does not include provisions for validation, verification, or approval of design changes. In addition, you explained that Commed, Inc. did not verify or validate a foam change in the design of the tracheostoma filters.
2. Failure to establish and maintain adequate procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50.
For example, your firm has not established purchasing control procedures. Furthermore, your firm did not maintain documentation of the evaluations of the contract manufacturer for the tracheostoma filters, and suppliers for the tracheostoma filters and stoma screens.
3. Failure to maintain complaint files and 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).
For example, your firm lacks documentation of two complaints received in 2011 via telephone regarding tracheostoma filters not sticking properly. You explained that your firm does not maintain complaint files and that the two complaints received were not documented. Your firm’s Quality System Complaint System and File procedure states, "In cases where a telephone complaint was made, a written summary of the complaint will be generated.”
4. Failure to establish and maintain adequate procedures to control product that does not conform to specified requirements and to address the identification, documentation, evaluation, segregation, and disposition of nonconforming product, as required by 21 CFR 820.90(a).
For example, you explained that Commed, Inc., does not document the disposition of non-conforming products identified during manufacturing. Specifically, you indicated that nonconforming product such as holes in the tracheostoma filters are observed, but not documented.
5. Failure to establish and maintain adequate procedures for acceptance of incoming product. Incoming product shall be inspected, tested, or otherwise verified as conforming to specified requirements and acceptance or rejection shall be documented, as required by 21 CFR 820.80(b).
For example, you explained that Commed, Inc., does not document the results of acceptance/rejection criteria for the tracheostoma filters received from its contract manufacturer. In addition, you explained that Commed, Inc., does not have written documentation of acceptance criteria used during the inspection of the tracheostoma filters received from its supplier.
6. Failure to establish adequate procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system, as required by 21 CFR 820.22.
For example, your firm’s Audit Schedule procedure requires an audit to be conducted at least annually. The most recent quality audit of your firm was conducted on September 09, 2004. The audit was performed by you, the owner (b)(4). However, quality audits are required to be conducted by individuals who do not have direct responsibility for the matters being audited.
7. Failure to implement procedures to ensure that Device History Records (DHRs) for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the Device Master Record (DMR), as required by 21 CFR 820.184.
For example, your firm has packaged, labeled, and distributed (b)(4) tracheostoma filters and manufactured and distributed (b)(4) stoma screens. However, your firm does not maintain DHRs for tracheostoma filters and stoma screens.
8. Failure to establish and maintain procedures to control all documents that are required by 21 CFR 820, as required by 21 CFR 820.40.
For example, your firm lacks procedures with requirements for documenting approval of quality system documents, including the date and signature of the individual approving the document.
Our inspection also revealed that the stoma screens are adulterated under section 501(f)(1)(B) of the Act, [21 U.S.C. § 351(f)(1)(B)], because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, [21 U.S.C. § 360e(a)], or an approved application for an investigational device exemption under section 520(g) of the Act, [21 U.S.C. § 360j(g)]. The device is also misbranded under section 502(o) of the Act, [21 U.S.C. § 352(o)], because your firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, [21 U.S.C. § 360(k)]. For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency [21 CFR 807.81(b)]. The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
Under section 510 of the Act [21 U.S.C. § 360], manufacturers of medical devices are required to annually register with the FDA. In September 2007, section 510 of the Act was amended by the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) to require domestic and foreign device establishments to submit their annual establishment registration and device listing information to the FDA by electronic means section 510(p) of the Act [21 U.S.C. § 360(p)] during the period of October 1st to December 31st of each year. Our records indicate that your firm has not fulfilled annual registration and listing requirements for fiscal year 2011.
Therefore all of your firm’s devices are misbranded within the meaning of section 502(o) of the Act, [21 U.S.C. § 352(o)], in that the devices were manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act [21 U.S.C. § 360] and were not included in a list required by section 510(j) of the Act [21 U.S.C. § 360(j)].
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 (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. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.
Your firm’s response should be sent to: U.S. Food and Drug Administration Seattle District Office, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021. Refer to the WL SEA 12-26 when replying. If you have any questions about the contents of this letter, please contact: Compliance Officer Lisa Althar at 425-302-0427.
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 FDA 483, Inspectional Observations, 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.
Charles M. Breen