September 30, 2015

Banyan Medical, LLC

The Food and Drug Administration (FDA) conducted an inspection of your firm’s medical device operation at 89 Bellows Street, Warwick, RI, from August 11 through 24, 2015. During the inspection, investigators from the United States Food and Drug Administration (FDA) determined that your firm is a specification developer of laparoscopic cannulas and trocars. 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 any function of the body.

Failure to establish and maintain procedures for validating device design to ensure that devices conform to defined user needs and intended uses to ensure that the results of the design validation, including identification of the design, method(s), the date, and the individual(s) performing the validation, is documented in the DHF, as required by 21 CFR 820.30(g). For example, design validation studies performed on your Banyan Cannula and Trocar Packs revealed the following deficiencies:

  • For report entitled, “Physical Bench Testing Study performed on Banyan Medical Cannula/Trocar new, accelerated and real time aged product, per GeoTec protocol 170004-01”, signed 2/28/2013”:
    • Your firm did not have an approved protocol that listed accepted specification criteria to demonstrate the finished products met your approved criteria.
    • We observed two separate versions (B) of the same report both dated February 28, 2013.  One version included failing bend testing results. The second version did not include the failing data and did not provide any explanation for the failing results.
    • For compression testing performed on the cannulas, there was no justification for various differences between the cannulas tested as part of this study; for example, the number of cannulas tested ((b)(4) vs. (b)(4)), the lengths tested ((b)(4) vs. (b)(4)), whether or not the cannulas had side ports, whether or not the samples were sterilized prior to testing, or whether or not the cannulas went through accelerated aging.
    • For the mechanical tensile testing performed on the trocars, there was no justification for various differences between the trocars tested as part of this study; for example, the number of devices tested ((b)(4) vs. (b)(4)), the length tested ((b)(4) vs. (b)(4)), the tip type ((b)(4) vs. (b)(4)), or aging ((b)(4)-year accelerated vs. date of manufacture).
    • For the mechanical puncture testing performed on the trocars, there was no justification for various differences between the trocars tested as part of this study; for example, the differences in quantities tested ((b)(4) vs.(b)(4)), length ((b)(4) vs. (b)(4)), tip type ((b)(4) vs. (b)(4)), or whether or not the samples were sterilized prior to testing.
    • There are no comparisons of results from one specific group to another to show if the results were within acceptable limits (i.e. test success or failure).
  • For report entitled, “Report of Shelf-Life of Banyan Medical Disposable Cannula and Trocar Accelerated and Real-time Aging Analysis dated 2/4/2013”:
    • There is no explanation for three failing sterile package peel strength tests.
    • Your firm has not conducted real time aging study for the Banyan Medical Cannula/Trocars as required by this report. The report summary states that thereal timeaging study should be completed by June 14, 2015; however this test has not yet been initiated.

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September 30, 2015

GeoTec, Inc.

The Food and Drug Administration (FDA) conducted an inspection of your firm’s medical device operation at 89 Bellows Street, Warwick, RI, from August 11 through 24, 2015. During the inspection, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures radio frequency cannulated (RFC) electrodes and laparoscopic cannulas and trocars. 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 any function of the body.

Failure to adequately validate with a high degree of assurance, a process whose results cannot be fully verified by subsequent inspection and test, as required by 21 CFR 820.75(a). For example, you have not adequately validated the Banyan Cannula and Trocar Packs manufactured by your firm. Review of two validation reports revealed the following deficiencies:

  • For report entitled, “Physical Bench Testing Study performed on Banyan Medical Cannula/Trocar new, accelerated and real time aged product, per GeoTec protocol 170004-01”, signed 2/28/2013”:
    • Your firm did not have an approved protocol that listed accepted specification criteria to demonstrate the finished products met your approved criteria.
    • We observed two separate versions (B) of the same report both dated February 28, 2013.  One version included failing bend testing results. The second version did not include the failing data and did not provide any explanation for the failing results.
    • For compression testing performed on the cannulas, there was no justification for various differences between the cannulas tested as part of this study; for example, the number of cannulas tested ((b)(4) vs. (b)(4)), the lengths tested ((b)(4) vs. (b)(4)), whether or not the cannulas had side ports, whether or not the samples were sterilized prior to testing, or whether or not the cannulas went through accelerated aging.
    • For the mechanical tensile testing performed on the trocars, there was no justification for various differences between the trocars tested as part of this study; for example, the number of devices tested ((b)(4) vs. (b)(4)), the length tested ((b)(4) vs. (b)(4)), the tip type ((b)(4) vs. (b)(4)), or aging ((b)(4)-year accelerated vs. date of manufacture).
    • For the mechanical puncture testing performed on the trocars, there was no justification for various differences between the trocars tested as part of this study; for example, the differences in quantities tested ((b)(4) vs.(b)(4)), length ((b)(4) vs. (b)(4)), tip type ((b)(4) vs. (b)(4)), or whether or not the samples were sterilized prior to testing.
    • There are no comparisons of results from one specific group to another to demonstrate that the results were within acceptable limits (i.e. test success or failure).
    • The Incoming Inspection Report could not be located for the components tested from one group (lot 10040531) of the Mechanical Puncture Test of Trocars.
  • For report entitled, “Report of Shelf-Life of Banyan Medical Disposable Cannula and Trocar Accelerated and Real-time Aging Analysis dated 2/4/2013”:
    • There is no explanation for three failing sterile package peel strength tests.
    • Your firm has not conducted a real time aging study for the Banyan Medical Cannula/Trocars as required by this report.  The report summary states that thereal timeaging study should be completed by June 14, 2015; however this test has not yet been initiated.

Download “FDA-Warning-Letter-for-GeoTec-Inc.pdf” FDA-Warning-Letter-for-GeoTec-Inc.pdf – Downloaded 62 times – 163 KB

Last Updated: 2015-10-08

Specification Developer and Manufacturer Hit with FDA Warning Letters
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