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U.S. Department of Health and Human Services

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Enforcement Actions

Primus Medical LLC 10/10/12

  

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

Public Health Service
Food and Drug Administration
 
Cincinnati District Office
Central Region
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
        FAX: (513) 679-2771

 

October 10, 2012                                           
 
 
WARNING LETTER                                                                      VIA UPS
CIN-13-364118-01
 
Michael Bruno, Owner
Primus Medical LLC
8401 Southern Blvd.
Boardman, OH 44512-6709
 
Dear Mr. Bruno:
 
During an inspection of your firm located in Boardman, OH on August 28 through 31, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is the specification developer and initial importer of AC powered hospital beds.  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 a response from Mark Shaw, President/Quality Representative, dated September 21, 2012, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations that was issued to your firm. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
 
1.      Failure to establish and maintain procedures to ensure that all purchased or otherwise received products and services conform to specified requirements, as required by 21 C.F.R. § 820.50. Specifically,
 
a)    Your “Vendor Evaluation and Quality” work instruction, WI-050-0140, dated 08/21/12, does not adequately establish and maintain the requirements, including quality requirements, that must be met by suppliers, contractors and consultants. For example, the requirements, including quality requirements, the contract manufacturer of the AC powered hospital beds must meet have not been established.
 
b)    All suppliers, contractors and consultants have not been evaluated on the basis of their ability to meet specified requirements, including quality requirements. For example, your contract manufacturer of the hospital beds has no evaluation documented. Additionally, only 8 of the 226 suppliers on your approved supplier list have been evaluated.
 
The adequacy of your firm’s response cannot be determined at this time. Your response states you are breaking down your suppliers into 2 groups, critical and non-critical, and updating the documentation that applies to each. The process of defining the appropriate levels of monitoring and tracking of supplier data is also being completed. A memorandum of understanding is being developed with your largest supplier. Please provide an update of this corrective action. If the timeframes discussed in your response cannot be met, please include the new timeframes.  
 
2.    Failure to perform design validation of the PCB301/601 Low Bed to ensure that these devices conform to defined user/patient needs and intended uses, as required by 21 C.F.R. § 820.30(g). Specifically,
 
Design validation was not performed on the new PCB301/601 Low Bed devices which have been distributed since June of 2012.
 
The adequacy of your firm’s response cannot be determined at this time. Your response states you are updating your validation procedure to assure better documentation of product validation. This device will be validated by October 25, 2012. Please provide an update on this corrective action including the new validation procedure and a summary of the validation when completed. If the timeframes discussed in your response cannot be met, please include the new timeframes.
           
3.    Failure to establish and maintain procedures to implement corrective and preventive action, as required by 21 C.F.R. § 820.100(a). Specifically,
 
Your CEO stated the “Corrective and Preventive Action” (CAPA) procedure, Rev 001, dated 8/23/2012 was just written and has not been implemented. No CAPA have been open.
 
The adequacy of your firm’s response cannot be determined at this time. Your response states you have formally begun using the new process, but you did not provide examples of the CAPAs that have been open or evidence of the weekly systematic reviews of the quality data.     Please provide an update, including documented evidence of these corrective actions.  If the timeframes discussed in your response cannot be met, please include the new timeframes.
 
4.    Failure to establish and maintain procedures that ensure complaints are evaluated to determine whether the complaint represents an event which is required to be reported to FDA under part 21 CFR 803, Medical Device Reporting (MDR), as required by 21 C.F.R. § 820.198(a)(3). Specifically,
 
All 31 complaints reviewed by the FDA investigator did not have a documented review for MDR reportablility.
 
The adequacy of your firm’s response cannot be determined at this time. Your response states you are reviewing the entire complaint process to ensure compliance. Please provide an update on this corrective action.  If the timeframes discussed in your response cannot be met, please include the new timeframes.
 
5.    Failure to review, evaluate and investigate, unless any such investigation has been performed for similar complaints and another investigation is not necessary, any complaint that involving the possible failure of a device, labeling or packaging to meet any of its specifications, as required by 21 C.F.R. § 820.198(c). Specifically,
 
A total of 7 of the 31 complaints reviewed by the FDA investigator did not have an investigation or the investigation was incomplete.
 
The adequacy of your firm’s response cannot be determined at this time. Your response states you are reviewing the entire complaint process and any files found to have inadequate documentation will be redone and/or the tests or analysis will be redone. Please provide an update on this corrective action. If the timeframes discussed in your response cannot be met, please include the new timeframes.
 
6.    Failure to document design verification results, including identification of the design, method(s), the date and the individual(s) performing the verification in the design history file (DHF), as required by 21 C.F.R. § 820.30(f). Specifically,
 
Two of the 17 specifications listed in your “PCB300 LOW BED System Requirement Specification” document were not verified. The following are these two specifications:
1) Bed must withstand the ascending step shock and 2) Bed does not over balance when placed on an inclined plane at an angle of 10 degrees from horizontal.
 
The adequacy of your firm’s response cannot be determined at this time. Your response states you are reviewing every test case from the PCB301/601 verification plan and re-writing them to make them both compliant with the regulation. Once the new procedure is written, it will then be used for all future test plans. Please provide an update on this corrective action. If the timeframes discussed in your response cannot be met, please include the new timeframes.
 
Our inspection also revealed that your firm’s 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 respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 - Medical Device Reporting.  Significant violations include, but are not limited to, the following:
 
Failure to develop written medical device reporting (MDR) procedures as required by 21 C.F.R. § 803.17.
 
The adequacy of your firm’s response cannot be determined at this time. Your response states MDR procedures will be developed by October 25, 2012; and all existing complaints will be reviewed to ensure compliance with MDR regulations by January 30, 2013.  Please provide an update on this corrective action including the new MDR procedure. If the timeframes discussed in your response cannot be met, please include the new timeframes.
 
Our inspection also revealed that your firm’s TL500 hospital beds 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 respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 806 – Medical Devices; Reports of Corrections and Removals. Significant violations include, but are not limited to, the following:
 
Failure to report in writing to the FDA a correction or removal, conducted to reduce a risk to health posed by a device, as required 21 C.F.R. § 806.10(a)(1)
 
  • On February 3, 2011, your firm determined that the corrective action to mitigate the risk of several complaints on the TL500 Low Bed’s pin at the top of the leg disengaging and causing the bed frame to come off tracks or collapse was to replace the retaining washers and pins on the bed. On March 29, 2011, a letter was sent to all customers who received this bed stating that “to avoid any potential failure and/or bed collapse, the “Retaining washers & Clevis Pins” must be replaced”. This correction and removal was not reported to FDA.

We reviewed your firm’s response and conclude that it is not adequate. Although you have reported the Correction and Removal to FDA, your response does not address how you will ensure future correction and removals that are required to be reported to FDA under 21 CFR Part 806 will be reported to FDA.

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 (including any systemic corrective actions) 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.
 
Your firm’s response should be sent to: 6751 Steger Drive, Cincinnati, OH 45237. Refer to CIN-13- 364118-01, when replying. If you have any questions about the contents of this letter, please contact: Gina M. Brackett, Compliance Officer at (513) 679-2700, extension 2167 or fax at (513) 679-2775.
 
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 yours,
/S/                                                           
Paul J. Teitell
District Director
Cincinnati District Office