Inspections, Compliance, Enforcement, and Criminal Investigations
Cederroth Industrial Products AB 1/20/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|10903 New Hampshire Avenue|
Silver Spring, MD 20993
JAN 20, 2011
VIA UPS EXPRESS
Ms. Maria Lundman Hedberg
Executive Vice President and Head of Wound Care Division
Cederroth Industrial Products AB
Box 715 Kanalvagen 10 A
SE-194 27 Uplands Vasby
Dear Ms. Hedberg:
During an inspection of your firm located in Upplands Vasby, Sweden on August 30, 2010 through September 2, 2010, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Cederroth breathing mask and 4-in-1 Bloodstopper. 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.
Our inspection revealed that the Cederroth breathing mask is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), because you do 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 (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g). The device is also misbranded under section 502(o) the Act, 21 U.S.C. 352(o), because you did not notify the agency of your 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) of the Act, 21 U.S.C. 360(k), is deemed satisfied when a PMA is pending before the agency. [21 CFR 807.81(b)] The kind of information you need to submit in order to obtain approval or clearance for your device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html.
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 FDA by electronic means (section 510(p) of the Act (21 U.S.C. 360(p)) during the period beginning October 1st and ending December 31st of each year. Our records indicate that you have not fulfilled your annual registration and listing requirements. Therefore all of your devices are misbranded within the meaning of section 502(o) of the Act (21 U.S.C. § 352(0)), in that the devices were manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 (21 U.S.C. § 360) and were not included in a list required by section 510(j)) (21 U.S.C. § 360(j)).
A follow up inspection will be required to assure that corrections and/or corrective actions are adequate.
In addition, FDA has observed violations with regard to section 501(h) of the Act (21 U.S.C. § 351(h)), which are deficiencies of the following Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at 21 CFR Part 820. These violations include, but are not limited to, the following:
1. Failure to establish and maintain adequate procedures, including quality requirements, that must be met by suppliers, contractors, and consultants, as required by 21 CFR 820.50(a). For example, requirements were not adequate to ensure that the (b)(4) process used by your firm's supplier (b)(4) for the Cederroth 4-in-1 Bloodstopper device was validated with a high degree of assurance and approved according to the document 'Technical Agreement" between (b)(4) and Cederroth Industrial Products AB, which was established in accordance with supplier control procedure CH 10-01.
Your response to this observation appears to be adequate.
2. Failure to establish and maintain adequate procedures for acceptance of incoming product. Incoming product will be inspected, tested, or otherwise verified as conforming to specified requirements, as required by 21 CFR 820.80(b). For example, your firm's acceptance procedure "CB 08-02-05" used for the acceptance of manufactured, sterile barrier packaged, and sterilized Cederroth 4-in-1 received from the contract manufacturer does not fully define how the (b)(4) will be tested. This procedure only defines that " (b)(4) " and that this will be done through "visual inspection and measuring". The procedure does not define how the (b)(4) will be tested.
We reviewed your response dated November 1, 2010 to this observation and conclude that the adequacy cannot be determined at this time. Your firm's performance data on the new validation process intends to be implemented with an effective date of September 13, 2010, and the incoming material inspection will be reviewed once the process validation results are at hand. Your firm stated CDRH would be notified by the beginning of December once all actions have been completed.
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.
Given the serious nature of the violations of the Act, Cederroth breathing masks manufactured by your firm are subject to refusal of admission under section 801(a) of the Act, 21 U.S.C. § 381(a), in that they appear to be adulterated, and misbranded. As a result, FDA may take steps to refuse these products, known as "detention without physical examination," until these violations are corrected. In order to remove the devices from detention, you should provide a written response to this Warning Letter as described below and correct the violation(s) described in this letter. We will notify you if your response is adequate, and we may need to re-inspect your facility to verify that the appropriate corrections have been made.
Also, U.S. 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 violation(s), or similar violation(s), 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. Please provide a translation of documentation not in English to facilitate our review.
Your response should be sent to: Charles Cathlin, 10903 New Hampshire Ave., Silver Spring, MD 20903. If you have any questions about the content of this letter please contact: Ron Berasa at 301-796-5589 or fax 301-847-8128.
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 violation(s) 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.
Steven D. Silverman
Office of Compliance
Center for Devices and