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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 01-Aug-05

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

Public Health Service
Food and Drug Administration

 

New York District
300 Pearl Street, Suite 100
Buffalo, NY 14202




August 1, 2005

WARNING LETTER NYK 2005-15

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

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

Dear Mr. Tobin:

The Food and Drug Administration (FDA) conducted an inspection of your Boston Scientific Corporation (BSC) medical device manufacturing facility located at 10 Glens Falls Tech Park, Glens Falls, New York, April 12, 2005 through May 6, 2005. Our inspection was limited to Low Profile Vaxcel Implant Chest Ports with PASV valves, Mini and Standard Vaxcel Implant Chest Ports with PASV valves, Introducer/Sheaths, and Vaxcel PASV 4.5F PICC Catheters. These products are medical devices as defined by section 201(h) [21 U.S.C. 321(h)] of the Federal Food, Drug, and Cosmetic Act (the Act).

During the inspection, FDA documented significant violations from the Quality System Regulation, Title 21 Code of Federal Regulations (CFR), Part 820. At the conclusion of the inspection, Form FDA 483, Inspectional Observations, was issued. On June 13, 2005, a revised Form FDA 483 was issued removing item 7. These violations cause the aforementioned medical devices manufactured at your firm to be adulterated within the meaning of section 501(h) [21 U.S.C. 352(h)] of the Act.

The following Quality System Regulation violations were observed and documented:

Procedures are inadequate to prevent acceptance of out-of-specification products, as required by 21 CFR 820.80(b). For example, an incorrect product specification was used to evaluate incoming lots of Low Profile Plastic Port subassemblies. As a result, four lots of subassemblies which failed to meet maximum dimensional height requirements were accepted for further manufacturing. In another example, inspection procedures for incoming lots of Introducer Sheaths which are packaged as received in Port Kits were inadequate to identify a problem resulting in numerous complaints from users. Investigation revealed the Introducer Sheaths were improperly scored resulting in users being able to peel the sheaths during use.

In-process tests that are used for final approval lack validation as required by 21 CFR 820.75(a). For example, in-process testing of Vaxcel Low Profile Ports with PASV valves is performed to determine if the values meet the minimum established specification of no leaks at 50 psi for 60 seconds using a fluid test. However, the leak test is routinely performed using another test method, the Water Submerge Bubble test, which has neither been validated, nor found to be equivalent to the fluid test. The Ports are routinely released for packaging and distribution without further leak testing and without assurances that the Ports have met this specification.

Acceptance/rejection procedures have neither been established nor implemented for finished lots of Vaxcel Low Profile, Mini, and Standard Chest Ports with PASV valves, or for Vaxcel PASV PICCS, as required by 21 CFR 820.80(d). As a consequence, these products were released for distribution without conducting final acceptance/rejection procedures following sterilization to determine the products meet all specifications.

The device history record fails to always include complete acceptance records that demonstrate the device is manufactured in accordance with the device master record, as required by 21 CFR 820.184(d). For example, an audit of thirty-eight leak test, device history records, revealed that the test method used, the pressure, and the time tested were absent. In another example, Quality Assurance procedure #6V87 requires that the original, signed Port Traceability form completed during QA's inspection of assembled Vaxcel Chest Ports with Attached lock is removed from each device history record and replaced by a photocopy. An audit revealed only thirteen of thirty-eight device history records contained photocopies as required. One original Port Traceability form was missing for lot #917111.

Complaints involving possible failures of devices to meet specifications are not always thoroughly investigated where necessary, as required by 21 CFR 820.198(c). For example:

  • Sixteen of twenty-one complaint records of investigation involving Introducer Sheaths used in Vaxcel Port kits failed to address either the root cause or follow up.(1)

  • Twelve of twenty-one complaint investigation records failed in obtaining return of the device for evaluation;(2)

  • Two of five complaint records of investigation involving Vaxcel Low Profile Ports with PASV kits failed to address the root cause or follow up;(3)

  • Six of nine Vaxcel Mini and Standard Ports with PASV kits complaint investigation records failed to identify the root cause or follow-up (4). The firm failed in three of nine instances to obtain return of the devices;(5)

  • Fourteen of nineteen complaint records of investigation records for Vaxcel PASV PICCs (IR/5/2) failed to identify the root cause or state the follow up.6 Four of nine such records failed to obtain return of the devices;(7)

  • Four of five complaint records of investigation for Vaxcel PASV PICCs (IR/5/1) failed to identify the root cause or follow up.(8) Two of five such records showed the firm failed to obtain return of the devices; (9) and

  • Ten of fourteen complaint records of investigation for Vaxcel PASV PICCs (CK/5/2) failed to identify the root cause or follow up.(10)

    Records of complaint investigations do not always include the full device identifications including the control numbers as required by 21 CFR 820.198(e) (3). For example:

  • six of twenty-one complaint records of Introducer Sheaths used in Vaxcel Port kits;(11)

  • two of five complaint records for Vaxcel Low Profile Chest Implant Ports;(12)

  • four of nine complaints for Vaxcel Mini and Standard Chest Implant Ports;(13)

  • twelve of nineteen complaints for Vaxcel PASV PICCs (IR5/2);(14)

  • three of five complaints for Vaxcel PASV (IR/5/1);(15) and

  • nine of fourteen complaints for Vaxcel PASV PICCs (CK/5/2).(16)

  • We are in receipt of Mr. John Watkins's letter dated May 31, 2005 and revised letter dated June 28, 2005, constituting Boston Scientific's written responses to Form FDA 483, issued May 6, 2005 and revised June 13, 2005. Review of these letters indicates most promised corrections constitute work in progress. In addition, several responses provide little detail regarding how your firm will achieve the desired corrections. For example, in your response to observation la, Incoming Inspection Procedures will be checked, but the letter fails to indicate against what trusted source. Regarding observation 1b, it is unclear in terms of specifics how your firm intends to verify that Braun's corrections and process controls are adequate. Regarding observation 3, the letter states the final release procedures for sterilized products performed at your Quincy facility are being reviewed and revised, but it does not address how final releases are being conducted in the interim period, prior to implementation of the corrective and preventive action. The comment regarding observation 6b has been duly noted and will be verified during our next inspection.

    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 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 drugs and devices so 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.

    You should take prompt action to correct these violations and to establish procedures to prevent recurrence. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.

    You should notify this office in writing, within fifteen (15) working days of receipt of this letter, of the specific additional steps you have taken to correct the noted violations, including an explanation of each step taken to prevent the recurrence of similar violations. If corrective action cannot be completed within fifteen (15) working days, please state the reason for the delay and the time by which the corrections will be completed. Correspondence should be directed to Compliance Officer William J. Thompson, U.S. Food and Drug Administration, at the above address, by telephone, 716-551-4461 (3124).

    Sincerely yours,

    /S/

    Jerome G.Woyshner
    District Director

    1 E.g. 636342, 641509, 642733, 644265, 645048, 647007, 647080, 652157, 652152, 652154, 650077, 651727, 651772, 651773, 651813, 651815.

    2 E.g . 636342, 640042, 641509, 644265, 645048, 652157, 652152, 652154, 650077, 651727, 651813, 651815.

    3 E.g . 646860, 649881.

    4 E.g. 628403, 634224, 637445, 639511, 639513, 639514.

    5 E.g . 639511, 639513, 639514.

    6 Eg. 634999, 636072, 636073, 636074, 636075, 636077, 636083, 634185, 641152, 641153, 641155, 641575, 641578, 641579.

    7 E.g . 641576, 641575, 641578, 641579.

    8 E.g . 637687, 637500, 645956, 645957.

    9 E.g. 645556 and 645957.

    10 E.g. 635156, 635300, 637348, 637349, 637350, 637352, 637354, 637355, 644796, 645595.

    11 E.g . 652157, 652152, 652154, 650077, 651813, 651815.

    12 E.g . 646355 and 648652.

    13 E.g . 634224, 639511, 639513, 639514.

    14 E.g . 636072, 636073, 636074, 636075, 636077, 636083, 636084, 634185, 637896, 637898, 641153, 641155.

    15 E.g. 637687, 637900, 639866.

    16 E.g. 637349, 637350, 637352, 637354, 637355, 643025, 645595, 645593, 643023 .