| Public Health Service Food and Drug Administration |
Waterview Corporate Center Telephone (973) 331-4906 |
Department of Health and Human ServicesAugust 11, 2010
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Mr. Christian Keller
President and CEO
Maquet Cardiovascular, LLC
45 Barbour Pond Drive
Wayne, NJ 07470
10-NWJ-14
Dear Mr. Keller:
During an inspection of your firm located in Wayne, New Jersey, on April 13, 2010 through May 14, 2010, investigators from the United States Food and Drug Administration (FDA) determined that your firm is a manufacturer of Hemashield Vascular Grafts and Fabrics (Hemashield Platinum Woven and knitted Double Velour Vascular Grafts, Hemashield Gold Woven and Knitted Double Velour Vascular Grafts). 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.
At the close of the inspection, FDA Investigators discussed with James L. Molly, Vice President of Quality, objectionable conditions observed during the inspection. A Form FDA-483 was issued to Mr. Molloy. We received a response from Mr. Bodo Anders, President and CEO for Vascular Interventions Business Unit, and Donald E. Kraft, Director of Quality Assurance, on June 7, 2010 concerning our investigator’s observations noted on the Form FDA 483, List of Inspectional Observations. The violations and Mr. Anders response are discussed below.
The FDA inspection revealed that your 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 (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. We address your firm’s response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
1. Failure to ensure that when the results of a process cannot be fully verified by subsequent inspection and test, that the process shall be validated with a high degree of assurance and approved according to established procedure. 21 CFR § 820.75(a).
Specifically, no cleaning validation was performed for your (b)(4) cleaning of vessels, surfaces, and other equipment used during the collagen impregnation process. Your firm’s laboratory simulation Disinfectant Efficacy Testing report, dated January 27, 2009 shows that the disinfectants used by your firm can remove microorganisms placed on carrier test coupons; however, no cleaning validation study was conducted to demonstrate that your (b)(4) cleaning and sanitizing procedures (Cleaning and Sanitizing-Collagen Blending Room, Document AE000013 Rev/Ver. AA, effective October 8, 2007 and Cleaning and Sanitizing-Hemashield Processing Room, Document # AE000001 Rev/Ver. AS, effective November 4, 2008) are adequate in removing contaminates from actual Collagen processing equipment. For example, your Collagen processing room includes large stainless steel (b)(4) blenders, coating vessels that include (b)(4) tubing which connects the coating vessel to (b)(4) spray nozzles, and benches which are used in the coating process.
We have reviewed your response pertaining to FDA-483 observation two and have concluded that your response was not adequate because of the following:
a) No information was provided in your response concerning CAPA WAY053 that was open to address the cleaning validation that was not performed and your investigation as to whether there are any additional cleaning processes that require validation within your current operations.
b) No training records were provided to show that this will not recur.
2. Failure to review and evaluate the process and perform revalidation where appropriate when changes or process deviations occur. 21 CFR § 820.75(C). Your firm failed to adequately revalidate the five year shelf life for your pouch and blister tray packages after the validation study failed to meet the acceptance criteria for mechanical peel test.
Specifically, package material Shelf Life Validation Protocol No. 90043268, Rev/Ver AA was executed to evaluate the shelf life of packages sterilized using new methods, including the (b)(4) and (b)(4), for pouch and blister tray packages using all material and sterilization combinations. The acceptance criteria for this protocol included a mechanical peel test where the peel test values shall exceed (b)(4). Your firm was to review all values to ensure that all are above (b)(4). However, five values fell below (b)(4) and these failures occurred on Seal #(b)(4), the seal created by your firm. Your firm concluded that all packages currently produced exhibit adequate seal integrity even though your entire acceptance criterion for this validation study was not met.
We have reviewed your response pertaining to FDA-483 observation three and have concluded that your response was not adequate because of the following:
a) Your firm states in your response that the decision to accept the five deviations was not adequately explained in the report, and you agree that the report had deficiencies that must be addressed (some date points failed to meet internal acceptance criteria). Your response promises a high level CAPA in order to develop a packaging re-validation strategy that is compliant with 21 C.F.R. § 820.75. However, no validation protocol or final report was provided for review.
b) No corrective actions were provided in your response to show that your firm will prevent the recurrence of accepting a validation report that does meet the entire acceptance criterion.
Our inspection also revealed that your Hemashield Vascular Grafts and Fabrics devices are 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 in respect to the device that is required by or under section 519 of the Act, 21 U.S.C. 360i, and 21 C.F.R. Part 806 – Reports of Corrections and Removals regulation. Significant deviations include, but are not limited to, the following:
Failure to submit a written report to FDA of any correction or removal of a device initiated to reduce a risk to health posed by the device or to remedy a violation of the act caused by the device which may present a risk to health, as required by 21 CFR 806.10(a).
For example, Boston Scientific, your firm which was located in Wayne, New Jersey sent a Customer Notification letter to your customers on December 6, 2006 regarding Hemashield Vascular Grafts and Fabrics to inform them that one of their customers lost control of the environmental controls (temperature and humidity) in a area known for extreme heat and humidity. This resulted in the formation of glycerol droplets on the inner blister of the product packaging for all Hemashield products. The letter informed your customers that if this situation should recur, it could lead to a prolongation of surgery which could potentially compromise patient safety. The customer notification letter requested your customers to review Hemashield products in their inventory for similar signs of exposure to extreme heat and humidity and to “contact your Boston Scientific Vascular Surgery Sales Representative to assist you in returning the unit(s)”. This recall was not reported to FDA.
In addition, the FDA investigator advised that you should consider performing a second voluntary recall action to cover all customers who could have any Hemashield products that could have the same conditions (formation of glycerol droplets) since a second moisture barrier product improvement (to correct and prevent the moisture condensation inside the Hemashield graft packaging) did not occur until December 12, 2008.
We have reviewed your response pertaining to FDA-483 observation one and have concluded that your response was not adequate because of the following:
a) Your response states that although you still believe you acted appropriately in this manner, you will send a Part 806 report to the New Jersey District Office Recall Coordinator. This inspection determined that Boston Scientific initiated a recall in 2006 requesting their customers to return various Hemashield products that may develop glycerol droplets on the inner blister of the package if not stored under proper conditions, which could lead to the prolongation of surgery and potentially compromise patient safety. However, these actions performed by Boston Scientific were not reported to FDA as a correction or removal of a device as required by 21 CFR 806.10(a). In addition, your firm has received complaints concerning the presence of droplets, moisture or condensation being present in the packaging of Hemashield Collagen coated grafts. Furthermore, it was discovered during this inspection that a second moisture barrier product improvement was made to correct and prevent moisture condensation in the Hemashield graft packaging. This change was effective December 12, 2008. However, your customers had not been notified of the issue of glycerol droplets until after FDA brought this issue to your attention. A letter was sent to your firm by FDA on July 21, 2010 stating that we reviewed your action regarding this issue and conclude it meets a definition of a “recall” (class II recall).
b) No corrective or preventative actions were implemented by your firm to prevent recurrence of the same violation.
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 FDA 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 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 violations, or similar violations, 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.
Your response should be sent to: Robert J. Maffei, Compliance Officer, U.S. Food and Drug Administration, 10 Waterview Boulevard, 3rd Floor, Parsippany, New Jersey, 07054. If you have any questions about the content of this letter, please contact Mr. Maffei at 973-331-4906.
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 violations noted in this letter and in the FDA-483 issued at the closeout of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.
Sincerely yours,
/S/
Diana Amador-Toro
District Director
New Jersey District Office
Cc: James L. Molloy
Vice President, Quality
Maquet Cardiovascular, LLC
45 Barbour Pond Drive
Wayne, NJ 07470
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