Inspections, Compliance, Enforcement, and Criminal Investigations

Banyan Medical, LLC 9/30/15

  

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

Public Health Service
Food and Drug Administration
 New England District Office
One Montvale Avenue, 4th floor
Stoneham, MA 02180
Phone 781.587.7500
Fax 781.587.7556 

 

WARNING LETTER
 
CMS # 480163
                                                                                                           
UNITED PARCEL SERVICE
OVERNIGHT DELIVERY
 
September 30, 2015
 
Mr. Thomas A. Jellison
CEO and Owner
Banyan Medical, LLC
89 Bellows Street
Warwick, RI 02888-1503.
 
Dear Mr. Jellison:
 
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.
 
This inspection revealed that these 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 requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. 
 
We received your response dated September 11, 2015 from Tammy A. Healey, Quality Manager which responded to the Form FDA 483, List of Inspectional Observations issued to your firm on August 24, 2015. Our comments regarding the adequacy of your response are included below.  Your significant violation is as follows:
 
1.    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 sideports, 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 the real timeaging study should be completed by June 14, 2015; however this test has not yet been initiated.
Your response is not adequate to address this violation. You have justified your rationale for the failures discussed on the FDA-483, but have not provided documentation to show that the above devices have undergone appropriate deign validation testing nor have you provided any documentation of real time stability testing.   In response to the Warning Letter, you should provide us with a description of the steps you are taking to remedy this violation, including any recent validation and stability testing conducted to correct this violation.
 
Your firm 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 FDA without further notice.  These actions include, but are not limited to, seizure, injunction, and civil money penalties.  Also, federal agencies may be advised of the issuance of 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 violations 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 business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again.  Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken.  If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities.  If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.
 
Please send your reply to the Food and Drug Administration, Attention: Karen N. Archdeacon, One Montvale Avenue, Stoneham, MA 02180. If you have questions regarding any issues in this letter, please contact Ms. Archdeacon at 781-587-7491.
 
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility.  It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA.  The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems.  Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance. 
 
Sincerely,
/S/ 
Amber G. Wardwell
Acting District Director
New England District Office

Page Last Updated: 10/09/2015
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