Inspections, Compliance, Enforcement, and Criminal Investigations
Probed Medical Technologies, Inc. 2/8/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|10903 New Hampshire Avenue|
Silver Spring, MD 20993
FEB 08 2012
VIA UNITED PARCEL SERVICE
Stephen B. Plummer
Probed Medical Technologies, Inc.
602-30930 Wheel Av
Dear Mr. Plummer:
During an inspection of your firm located in Abbotsford, Canada, on September 12 through September 15, 2011, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Freedom Bed. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321 (h), this product is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body.
This inspection revealed that the device is 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, its 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 firm's response, dated September 30, 2011, concerning our investigator's observations noted on the Form FDA 483 (FDA 483), lnspectional 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 adequate procedures for identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(i). For example:
• Complaint 429 was received on November 1, 2009, and described the Freedom Bed as having a "clunk" noise during rotation. Your firm determined that the rocker plate mounting bracket P30-2020 was moving slightly under load. Your firm initiated a change via (b)(4) and changed the bolt size from (b)(4) Your firm failed to document the validation or where appropriate, verification of the design change to ensure that the action was effective and that the design change did not adversely affect the finished product.
• A design change was implemented on October, 2008, (b)(4) Your firm did not document that the design change was validated or where appropriate, verified to ensure that the patient can be elevated (b)(4) and rotated without the patient falling out of the bed.
We reviewed your firm's response and conclude that it is not adequate. While the response promised to modify the procedure for design change, your firm failed to provide a copy of the modified procedure for review, and verification that a retrospective review of all verification activities was performed for all design changes across all devices.
2. Failure to establish and maintain adequate procedures for finished device acceptance to ensure that each production run, lot or batch of finished devices meets acceptance criteria as required by 21 CFR 820.80(d). For example:
• There are no written procedures detailing the complete scope of the finished product testing. Specifically, the hand control, side rail and battery charger testing are not covered in the (b)(4) procedure, MP018. Your firm drafted a document on September 14, 2011 , after the inspection with the proposed additions to the (b)(4) procedure, MP018.
We reviewed your firm's response and conclude that it is not adequate. The response confirmed that the hand control, side rail, and battery charger have been tested, however, there is insufficient documentation to support that the procedure has been revised with testing. Also, there is no evidence that training was conducted on the new procedure or that all tests for all devices are written into a similar procedure.
3. Failure to establish and maintain adequate requirements, including quality requirements that must be met by suppliers, contractors, and consultants and to define the type and extent of control to be exercised over the product, services, suppliers, contactors and consultants, based on the evaluation results, as required by 21 CFR 820.50(a)(2). For example:
• Supplier approval procedure, SOP-014- (b)(4) fails to clearly define the extent of control to be exercised over suppliers. The procedure does not define the requirements, such as frequency of monitoring, necessary for varying types of suppliers.
We reviewed your firm's response and conclude that it is not adequate. Your firm failed to submit the updated documentation which includes the timeframe when the Class 2, 3 and 4 vendors are assessed and re-audited in order to demonstrate they have implemented a correction and corrective action for the deficiency.
4. Failure to establish adequate procedures for quality audits to include audits which are conducted by individuals who do not have direct responsibility for the matters being audited, as required by 21 CFR 820.22.
• For example, the audits of the management controls and CAPA subsystems were performed by a third party auditor. However, the auditor also participates in management review meetings and determines the corrective and preventive actions for the issues he previously audited.
We reviewed your firm's response and conclude that it is not adequate. The response failed to address whether or not the auditor would be excluded from management review meetings in determining corrective and preventative actions. Given the serious nature of the violations of the Act, the Freedom Bed, manufactured by your firm is subject to refusal of admission under section 801 (a) of the Act, 21 U.S.C. § 381 (a), in that it appears to be adulterated. As a result, FDA may take steps to refuse these products, known as "detention without physical examination," until these violations are corrected. In order to remove the devices from detention, your firm should provide a written response to this Warning Letter as described below and correct the violations described in this letter. We will notify you if your firm's response appears to be adequate, and we may need to re-inspect your firm's facility to verify that the appropriate corrections and/or corrective actions have been made.
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 III devices to which the Quality System regulation deviations 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, 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 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. Please provide a translation of documentation not in English to facilitate our review.
Your firm's response should be sent to: Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, Field Operations Branch, White Oak Building 66, Rm 2609, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case #262754 when replying. If you have any questions about the contents of this letter, please contact: Latoya Oliver-Powell, General Hospital Devices Branch, at 1(301) 796-5648 (phone) or 1(301) 847-8137(fax).
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 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.
Steven D. Silverman
Office of Compliance
Center for Devices and