Inspections, Compliance, Enforcement, and Criminal Investigations

Amico Beds Corporation 9/1/15

  

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

Public Health Service
Food and Drug Administration
 10903 New Hampshire Avenue
White Oak Building 66
Silver Spring, MD 20993

 

WARNING LETTER

 
September 1, 2015

 
VIA UNITED PARCEL SERVICE
 
Paul Phagoo
General Manager
Amico Beds Corporation
121 Granton Drive, #21
Richmond Hill, Ontario L4B 2N4
Canada
 
Dear Mr. Phagoo:
 
During an inspection of your firm located in Richmond Hill, Ontario, Canada on March 9, 2015, through March 12, 2015, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures A/C powered adjustable 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 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 your firm dated March 31, 2015, concerning our investigator's observations noted on the Form FDA 483 (FDA 483), List of lnspectional Observations, which 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 for validating the device design as required by 21 CFR 820.30(g).  For example:
 
a.  Procedure (b)(4),"DesignControl," does not require that design validation be conducted underdefined operating conditions using initial production unitsor their equivalents.
 
b.  No design validation study was conducted to demonstrate that the design of the Apollo Medsurg Powered Bed addresses user needs and intended uses of the device under defined operating conditions using initial production units or their equivalents.
 
We reviewed your firm's response and concluded that it is not adequate. Specifically, retrospective validations have not been conducted.
 
2.    Failure to adequately establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). For example, Procedure QOP-14-01, "Corrective and Preventive Action," (CAPA) defines how to execute CAPAs, including investigating for root cause, developing a corrective action plan, and verifying/validating the effectiveness of a CAPA.  Five out of five available CAPA reports did not document corrective action implementation and/or verification/validation of the effectiveness of the corrective action.
 
We reviewed your firm's response and concluded that it is not adequate. The corrective actions detailed in your firm's response have not yet been completed. Additionally, the response did not include information showing the five CAPAs mentioned above were corrected in addition to systematic consideration of the issue.
 
3.    Failure to establish and maintain adequate procedures to ensure that Device History Records (DHRs)  for each batch, lot, or unit are maintained to demonstrate that the device is manufactured  in accordance with the Device Master Record as required by 21 CFR 820.184.  For example, (b)(4), "Final Inspection," governs documentation for final product inspection. It requires that a green sticker be put on product released for shipment, and that the individual releasing the product sign and date the final inspection form. Device history records for the Apollo Medsurg Bed do not contain the following items: documentation of application of the green release sticker and the signature of the individual applying the sticker; and a copy of the primary identification label applied to the product.
 
We reviewed your firm's response and concluded that it is not adequate. Specifically, your firm has not retrospectively reviewed the original DHRs. Please provide a plan for retrospective review and correction, as necessary, of DHRs.
 
4.    Failure to adequately establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system, as required by 21 CFR 820.22.  For example, (b)(4), "Internal Quality Audits," requires that members of the audit team be independent of the area or activity being audited. It further states that QA personnel normally audit most areas and that operations personnel normally audit QA areas. The Internal Audit Document for 2014 documents only that the QA Manager was an auditor, and does not indicate that QA areas were audited by another person, or that there were any other auditors involved in the audit.
 
We reviewed your firm's response and concluded that it is not adequate.  The procedure (b)(4) has been revised to outline proper usage of the "Internal Audit Matrix". However, the response does not include an analysis of previous audit information to ensure audits were performed by an independent auditor. Additionally, your firm has not yet provided documentation of the implementation of the correction and corrective action.
 
Our inspection also revealed that the Apollo Medsurg Powered Hospital Bed is 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 regarding the devices 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 deviations include, but are not limited to:
 
5.    Failure to develop, maintain and implement written MDR procedures, as required by 21 CFR 803.17. For example, after reviewing your firm's MDR procedure titled "(b)(4), Medical Device Remedial Actions", Revision: C, undated, the following issues were noted:
 
a.  (b)(4), Revision C does not establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements. For example:
 
There are no definitions of what your firm will consider to be a reportable event under 21 CFR Part 803. The exclusion of definitions from 21 CFR 803.3 for the terms "become aware," "caused or contributed," "malfunction," "MDR reportable event," and "Serious injury," and definitions for the terms "reasonably known" and "reasonably suggests," found respectively in 21 CFR 803.50(b) and 803.20(c)(1), may lead to an incorrect reportability decision when evaluating a complaint that may meet the criteria for reporting under 21 CFR 803.50(a) .
 
b.  (b)(4), Revision C does not establish internal systems that provide for a standardized review process to determine when an event meets the criteria for reporting under this part. For example:
 
i.  There are no instructions for conducting a complete investigation of each event and evaluating the cause of the event.
 
ii.  The procedure, as written, does not specify who makes the decision for reporting events to FDA.
 
iii.  Although the procedure includes instructions for how your firm will evaluate information about an event to make MDR reportability, it fails to include instructions for making determinations in a timely manner.
 
c.  (b)(4) does not establish internal systems that provide for timely transmission of complete medical device reports. Specifically, the following are not addressed:
 
i.  The procedure does not contain or refer to instructions for how to obtain or complete the FDA 3500A form.
 
ii.  The circumstances under which your firm must submit initial 30-day, supplemental or follow-up and 5-day reports and the requirements for such reports.
 
iii.  How your firm will submit all information reasonably known to it for each event.
 
iv.  The procedure does not include the address for where to submit MDR reports: FDA, CDRH, Medical Device Reporting, P.O. Box 3002, Rockville, MD 20847-3002.
 
d.  (b)(4) does not describe how your firm will address documentation and record-keeping requirements, including:
 
i.  Documentation of adverse event related information maintained as MDR event files.
 
ii.  Information that was evaluated to determine if an event was reportable.
 
iii.  Documentation of the deliberations and decision-making processes used to determine if a device-related death, serious injury, or malfunction was or was not reportable.
 
iv.  Systems that ensure access to information that facilitates timely follow-up and inspection by FDA.
 
The adequacy of your firm's undated response for Observation #5 cannot be determined at this time. In the response, your firm noted that it will develop a separate procedure to address reportability of events to FDA. This documentation has not yet been received for FDA review.
 
The eMDR Final Rule requiring manufacturers and importers to submit electronic Medical Device Reports (eMDRs) to FDA was published on February 13, 2014. The requirements of this final rule will take effect on August 14, 2015. If your firm is not currently submitting reports electronically, we encourage you to visit the following web link for additional information about the electronic reporting requirements: http://www.fda.gov/Forlndustry/FDAeSubmitter/ucm107903.htm
 
If your firm wishes to discuss MDR reportability criteria or to schedule further communications, it may contact the Reportability Review Team by email at ReportabilityReviewTeam@fda.hhs.gov
 
U.S. 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 Illdevices to which the Quality System regulation deviations are reasonably related will not be approved until the violations 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, including 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 action (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.  Please provide a translation of documentation not in English to facilitate our review.  We will notify you regarding the adequacy of your firm's response(s) and the need to re-inspect your firm's facility to verify that the appropriate corrections and/or corrective actions have been made.
 
Your firm's response should be sent to: Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, Field Inspections Support Branch, White Oak Building 66, Rm 2622, 10903 New Hampshire Ave., Silver Spring, MD 20993.  Refer to CMS case #470343 when replying.   If you have any questions about the contents of this letter, please contact: Daniel Walter, Chief, Foreign Enforcement Branch, at telephone 301-796-6110  or fax 301-847-8139.
 
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 lnspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality managementsystems.  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/ 
Jan B. Welch, MHS, MT (ASCP) SBB
Acting Director
Office of Compliance
Center for Devices and
Radiological Health
  
U.S. Agent:
AJW Technology Consultants, Florida.
 

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