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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Boston Scientific Corporation 18-May-05

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

New England District
One Montvale Avenue
Stoneham, Massachusetts 02180
(781) 596-7700
FAX: (781) 596-7896



WARNING LETTER

NWE-06-05W

VIA FEDERAL EXPRESS

May 18, 2005

Mr. James Tobin
President / CEO
Boston Scientific Corporation
One Boston Scientific Place
Natick, MA 01760-1537

Dear Mr. Tobin:

We are writing to you because on March 9 through April 7, 2005, the Food and Drug Administration (FDA) conducted an inspection of your Boston Scientific Corporation, (BSC) Watertown, Massachusetts facility which revealed serious regulatory problems involving your implantable Vaxcel Low Profile Infusion Ports.

Under a United States law, the Federal Food, Drug and Cosmetic Act, (the Act) this product is considered to be a medical device because it is used to diagnose or treat a medical condition. Moreover, your activities, including the, manufacture of the ports, make you a manufacturer under the law.

Our inspection revealed that you manufacture six different types of Vaxcel Low Profile Infusion Ports. Three contain valves with PASV( pressure activated safety valve) technology (valved ports), (BSC Order numbers 45-233, 45-236 and 45-238) and three do not have a PASV valve (non-valved ports), (BSC Order numbers 45-333, 45-336 and 45-338).

The inspection, found that these devices are adulterated under section 501(h) of the Act, in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage or installation are not in conformance with the Current Good Manufacturing Practice (CGMP) requirements for medical devices which are set forth in the Quality System regulation, as specified in Title 21 Code of Federal Regulations, (21 CFR), Part 820. Significant deviations include, but are not limited to, the following:

1. Failure to establish adequate management controls to ensure that an effective quality system has been established and maintained as required by 21 CFR 820.20.

For example, the responsibilities for quality problems of your Vaxcel product line, including complaints, are shared by at least five different Boston Scientific Corporation facilities. Process requirements and written procedures are not consistent at the facilities that handle the Vaxcel product line to ensure that an effective quality system has been established and maintained. See the FDA-483 that was issued at the Watertown MA facility on April 7, 2005 which listed nine observations relating to the manufacture of the Vaxcel Low Profile Infusion Ports. A copy of this FDA-483 is attached. We also note that a copy was forwarded to you after, the inspection in a letter
dated April 8, 2005.

2. Failure to validate your manufacturing process with a high degree of assurance to ensure that specified requirements are met as required by 21 CFR 820.75(a).

For example, the Vaxcel Low Profile Infusion Ports were not validated adequately to assure that the ultrasonic weld, used on all six of your Vaxcel Low Profile Infusion Ports, achieved the proper weld' strength. Your Corporate Form Product Inquiry Report, (PIR) WAT2004-08-01 initiated August 26, 2004, after one complaint of port separation, indicated that the root cause determination was that the port separation may be due to an insufficient ultrasonic weld. There was no distinction made that non valved units, that also utilized the ultrasonic weld, would be unaffected.

We also note that during the inspection, your firm indicated that the initial validation for the ultrasonic welding process, used to weld the port to the base, was the same for the non-valved and valved units: However, On April 6, 2005, you provided our Investigator with a rationale entitled, "Vaxcel Low Profile Plastic Port Non-Valved justification". This states that "Although the same welding validation was used to release both the valved and non valved product, differences in the design and changes to the manufacture of Valved port since this validation demonstrates the two ports yield different weld strength." This statement, however, does not provide sufficient assurance that the requirements of 21 CFR Part 820.75(a) have been met.

We understand that you are currently performing validation activities on both the valved and non-valved units, however, you have not provided sufficient data to demonstrate that the non valved ports, that are currently on the market, have been validated initially as required by 21 CFR 820.75(a).

&. Failure to establish and maintain an adequate corrective and preventive action procedure which ensures identification of actions needed to correct and prevent the recurrence of nonconforming product and other quality problems, as required by 21 CFR 820.100(a)(3). For example:

a. As stated above, the same welding validation was used to release both the valved and non-valved product prior to its release for introduction into the market. Upon receipt of one complaint of port separation on August 19, 2004 of the valved port BSC order # 45-238, you instituted a "Precautionary" shipping hold on only the three valved products, to prevent further distribution of these devices. You have since received four additional complaints alleging port separation on September 2, 2004, October 19, 2004, November 16, 2004 and February 9, 2005. On March 11, 2005, you implemented a voluntary recall of all your Vaxcel Low Profile Valved ports. You have provided a document, dated April 6, 2005, entitled, "Vaxcel Low Profile Plastic Port Non-Valved justification," which was provided as the rationale for not including the non-valved units in your voluntary recall. This document states, "To date Boston Scientific is not aware of any complaints for Port separation on the Non Valved product."

Moreover, on March 18, 2005, during the inspection, you provided our Investigator with a document entitled, "Vaxcel Low Profile Plastic Port Non-Valved Rationale". This document states, "Within this timeframe, there have been no complaints associated to port housing (base-cover) separation for the non-valved plastic port".

However, we note that on January 5, 2005 you received a complaint from [redacted] (#651691) on the non-valved port, (BSC order # 45-338). The complaintt description on this complaint indicated there was a "leak in the membrane ceptum (sic) and port meet". The root cause identified on the complaint was noted as "customer use" and was not considered in the evaluation of an insufficient ultrasonic weld.

b. We also note that your Corporate Form Product Inquiry Report, (PIR) WAT2004-08-01, was initiated on August 26, 2004 to investigate the first failure related to port separation. The PIP, was based on the receipt of one complaint of port separation received by your firm on August 19, 2004. The PIR indicates that, "No assignable cause has been identified for the isolated weld failure. . . . No field action is recommended at this time. QA will continue to monitor field reports for any additional events and update the PIR accordingly." (emphasis added). We note that your firm received a second complaint dated September 2, 2004 from [redacted] that indicated, "upon removal, the port body came apart in multiple pieces." There was no indication in the PIR of a discussion of this potential second event of port separation. This PIR was signed off by Boston Scientific representatives on September 24, 2004, September 27, 2004 and September 29, 2004. In fact we note that your firm received three additional complaints of port separation on October 19, 2004, November 16, 2004 and February 9, 2005 yet the PIR was not updated until February 23, 2005.

4. Failure to validate changes to your manufacturing process with a high degree of assurance to ensure that specified requirements are met as required by 21 CFR 820.75(c).

On July 10, 2003, your firm instituted a change to the valyed Low Profile Infusion Ports to sand the port bases. This was done to [redacted] validation of this change consisted only of verifying that the height of the base was still within specifications, prior to welding. Validation did not include verification assurance that the changes did not affect the ultrasonic weld of the device.

We note that during the inspection you indicated that all subsequent, confirmed port separation complaints were on ports that included this change, ie., were sanded.

5. Failure to identify the acceptance status of product throughout manufacturing, packaging, labeling, and servicing of the product to ensure that only product which has passed the required acceptance activities is distributed or used as required by 21 CFR 820.86.

For example, the Vaxcel Low Profile Infusion Ports with PASV valve were placed on a "Precautionary" shipping hold on August 25, 2004 due to one complaint of port separation . Additional complaints alleging port separation were received by your firm on September 2, 2004, October 19, 2004, November 16, 2004 and February 9, 2005. However, Vaxcel Low Profile valved ports remained in use until a field action was instituted by your firm on March 11, 2005.

6. Failure of your firm to establish procedures to completely address the identification, documentation, evaluation, segregation, disposition and investigation of non-conforming product as required by 21 CFR 820.90(a).

For example, procedures are lacking to assure consistency in the handling and timing activities from complaint receipt, complaint trending, ship hold, PIR initiation, and field action determination, to actual recall . In examining three different Boston Scientific voluntary recalls relating to Vaxcel subassemblies manufactured in Watertown, there were a number of inconsistencies. See the details listed on the FDA- 483 #5.

This letter is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure adherence to each requirement of the Act and regulations. The specific violations noted in this letter and in the Form FDA-483 issued at the conclusion of the inspection may be symptomatic of serious underlying problems in your establishment's quality system. You are responsible for investigating and determining the causes of the violations identified by the FDA. You also must promptly initiate permanent corrective and preventive action on your Quality System.

You should know that these serious violations of the law may result in FDA taking regulatory action without further notice to you. These actions include, but are not limited to, seizing your product inventory, obtaining a court injunction against further marketing of the product, or assessing civil money penalties.

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, no premarket submissions for Class III devices to which the Quality System/Current Good Manufacturing Practice deficiencies are reasonably related will be cleared or approved until the violations have been corrected. Also, no requests for Certificates to Foreign Governments will be approved until the violations related to the subject devices have been corrected.

We acknowledge the receipt of a letter, signed by Mark S. Adams, Quality Manager on April 21, 2005, which responded to the FDA 483 that was issued to your facility on April 7, 2005. We note that your response fails to address specific system wide corrective actions that are necessary to bring your facility into compliance. For example, in response to the failure to implement an effective quality organization as noted in our FDA-483 item 6, your letter states that you will "review and harmonize the complaint investigation procedures across the corporation." The violations included in this Warning Letter and discussed above concern significant deficiencies across all of your quality systems, including corrective and preventive actions (CAPA's), that warrant your immediate attention to assure that an effective quality system is in place.

We also acknowledge that in your letter, you have requested a meeting with our office to discuss these recent findings. Upon receipt and review of this Warning Letter, you may call me to arrange a convenient time to discuss the findings.

You may wish to contact the Recall Coordinator, Susan Liner, in FDA's New England District Office at 781-596-7750 to discuss the Vaxcel non-valved Low Profile Infusion Ports currently in commercial distribution.

It is necessary to take action on this matter now. Please let this office know in writing what steps you have taken to correct the noted problems within fifteen (15) working days from the date you received this letter . We also ask that you explain how you plan to prevent these problems from happening again. If you need more time, let us know why and when you expect to complete your correction. Please direct your response or any questions you may have to Karen Archdeacon, Compliance officer, Food and Drug Administration, One Montvale Avenue, 4th Floor, Stoneham, Massachusetts 02180. Her telephone number is (781) 596-7707; FAX No 781-596-7899.

Sincerely yours,


/S/

Bruce I. Skolnick
Deputy Regional Food and Drug Director
Northeast Region