Inspections, Compliance, Enforcement, and Criminal Investigations
Medical Positioning Inc. 4/18/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Kansas City District|
11630 West 80th Street
Lenexa, Kansas 66214-3340
Telephone: (913) 752-2100
April 18, 2011
RETURN RECEIPT REQUESTED
Ref: KAN 2011-07
Laura L. Brady, President and Chief Executive Officer
Medical Positioning Inc.
1717 Washington Street
Kansas City, MO 64108
Dear Ms. Brady:
During an inspection of your firm located in Kansas City, MO on 12/20/2010 through 1/11/2011, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures radiographic tables and electrocardiograms. 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 are intended to affect the structure or function of the body.
Our 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 (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.
We received a response from Joe Hurtig, Quality Manager dated January 20, 2011 concerning our investigator's observations noted on the Form FDA 483, List of Inspectional Observations that was issued to you. We address this response below, in relation to the noted violations. These violations include, but are not limited to, the following:
1. Failure to establish and maintain adequate procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a).
For example, your Corrective and Preventive Action (#(b)(4)) procedure does not address the necessary requirements of the corrective and preventive action system, such as analyzing processes and other forms of quality data to identify existing and potential problems. The procedure also lacks requirements for documentation of corrective and preventive actions; therefore no corrective and preventive actions have been documented.
2. Failure to establish and maintain adequate procedures to ensure all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820,50.
For example, the quality manager stated that qualification of vendors is not documented since the vendor/supplier/consultant evaluation (#(b)(4)) procedure does not require documentation of supplier evaluation, This procedure also lacks information on the defined levels of control for suppliers, consultants and contractors and does not require purchasing data.
3. Failure to establish and maintain adequate procedures to ensure the 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, DHRs for beds manufactured between 10/27/2010 and 12/20/2010, (approximately (b)(4) records) were reviewed, and none contained primary identification labeling; 25 of the records had incomplete acceptance records. Further instances included: 1. DHR for bed serial # 601593 had no documentation of the batch number for the bed frame but was still signed as inspected and released. 2. Four (4) beds (serial #'s 601601,601648, 601649,and 601662) were released without inspection, 3. Two (2) DHRs for beds (serial #'s 6016015, 601612) failed to include documentation of testing, 4. Two (2) DHRs (serial #'s 601574, 601569) lacked the serial number for the motor components, and 5. Sixteen (16) DHRs (serial #'s 601681, 601661, 601577, 601576, 601575, 601574, 601572, 601571, 601569, 601559, 601558, 601557, 601552, 601551, 601549, 601548,) only contained the initials of the inspector and lacked documented inspection and release data The investigator also noted there is no procedure related to the completion of device history records.
4. Failure to maintain device master records (DMRs) and to ensure that each (DMR) is prepared and approved as required by 21 CFR 820.181.
For example, your firm's Device Master Record for Echo Tables (EPS 500) does not contain or refer to the location of current specifications, production methods and procedures, acceptance criteria, packaging and labeling specifications, and the installation and servicing procedures.
5. Failure to establish and maintain adequate procedures to control all documents, as required by 21 CFR 820.40.
For example, your firm's procedures for document control are defined in Document Control Procedure #(b)(4). However, documents including, but not limited to Product Incident Report (PIR) review process, Medical Device Reporting (MDR) flowchart, Corrective and Preventive Action (CAPA) procedures, and product inspection processes do not have approval signatures and dates for the most recent revisions and have incomplete document change records.
6. Failure to establish and maintain adequate procedures for design transfer as required by 21 CFR 820.30(h).
For example, your firm's procedures for design transfer are defined in Quality Design Control Procedure #(b)(4). However, design changes were made to the base frame of the Echo beds and tables on and as of 1/5/2011 the Device Master Record for the Echo beds and tables did not have the specifications for the new base frame, but instead contained specifications for a previous bed frame approved on
7. Failure to establish procedures for identifying training needs, ensuring that all personnel are trained to adequately perform their assigned responsibilities, and that all training shall be documented as required by 21 CFR 820.25(b).
For example, your firm has no training procedures and does not document employee training or qualification. Your firm had two significant changes in management personnel in (b)(7)(C) and a new manufacturing employee was hired in (b)(7)(C). No training was documented for any of the three new employees.
8. Failure to establish and maintain adequate design validation procedures to ensure that devices conform to defined user needs and intended uses; to ensure proper risk analysis is completed; and to ensure the results of the design validation, including identification of the design, methods, the date, and the individuals performing the validation are documented in the design history file, as required by 21 CFR 820.30(g).
For example, risk analysis for the General Surgical and Pain Management (GSPM) Table has been revised to include more problem listings, risk reduction requirements, and verification/validation of changes. However, the analysis does not contain a scoring system. Harm severity levels, probability of harm, and priority levels are assigned numbers, but there is no key identifying the scoring range, scoring calculation, or scoring of risk reduction activities.
9. Failure to establish and maintain adequate procedures to ensure formal documented reviews of the design results are planned and conducted at appropriate stages of the device's design development, to ensure that participants at each design review include representatives of all functions concerned with the design stage being reviewed, and an individual(s) who does not have direct responsibility for the design stage being reviewed, as well as any specialists needed. Also, there is a failure to document the results of a design review, including identification of the design, the date, and the individual(s) performing the review, in the design history file (the DHF), as required by 21 CFR 820.30(e).
For example, your firm's Quality Design Controls procedure (#(b)(4) ) does not ensure formally documented reviews are conducted at appropriate intervals in the design development and does not ensure that participants of reviews include representatives of all functions concerned with the design stage being reviewed as well as an individual who does not have direct responsibility for the stage being reviewed.
Our inspection also revealed that your radiographic tables and electrocardiogram 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 (MDR) regulation. Significant violations include, but are not limited to, the following:
1. Failure to submit an MDR report within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to death or serious injury of the malfunction were to recur as required by 21 CFR 803,50(a)(2).
For example, on 11/9/2009 your firm became aware of a MultiScan Table (#597108) which collapsed with a patient on it. Your firm's PIR #(b)(4) states the patient avoided injury by grabbing the safety rails when the head section of the table fell to the floor after the weld on the lower Fowler actuator mounting tab failed. In a previous incident on 8/5/2009, reported in PIR #(b)(4), a MultiScan Table (#596984) collapsed immediately following use without the patient on the table, The head of the table fell to the floor after the weld on the lower Fowler actuator mounting tab failed. On 1/7/2011 your Quality Manager confirmed this was a repeat of weld problem identified on other models of tables in 2007 following several reportable events (MedWatch Reports: (b)(4),(b)(4),(b)(4),(b)(4),(b)(4) all of which involved the head section of the bed falling to the ground and patients falling or sliding off the table following the failure of either the Trendelenberg or Fowler actuator mounting tab. On 11/18/2009, your firm contacted customers of (b)(4) remaining MultiScan and Echo Tables about replacing frames on tables with evidence of cracking welds and installing safety brackets on beds without cracked welds to prevent collapse should the weld eventually fail.
Our inspection also revealed that your radiographic tables and electrocardiogram 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 806 - Reports of Corrections and Removals regulation. Significant violations include, but are not limited to, the following:
1. Failure to provide all the required information when you reported your correction/removal via a MedWatch Report. Specifically, information required by a 21 CFR 806.10(c)(11). It should be noted that your firm's field action ("safety correction") was reviewed by the FDA and determined to meet the threshold for a Class II Recall.
For example, the correction of MPI's RR H.U.T. tables was reported to the FDA through MedWatch #(b)(4). This report did not contain required information regarding the consignees contacted in the correction. During the inspection, the Quality Manager provided a listing of the names and addresses of affected consignees and the phone numbers through which consignees were contacted. The Quality Manager stated he was unaware of the corrections and removal reporting and recordkeeping requirements.
2. Failure to Justify why its correction/removal actions were not reported to FDA, including the information required by 21 CFR 806.20(b)(4).
For example, your firm's records for the "Ultra Scan Foot Drop Correction" and the "Fowler Positioning Assist Cylinder Service Bulletin" did not contain justification for not reporting the corrections to the FDA, nor did it include conclusions, follow-ups, or reviews by a designated individual.
We reviewed your response to the above listed observations and conclude it is not adequate based on the following: You did not provide any evidence of completed corrective actions identified as being completed, the effectiveness criteria established for evaluating corrective actions are vague and immeasurable, and you did not perform an overall evaluation of the impact these observations had on your systems as a whole.
You 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 Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, federal agencies are advised of the issuance of all 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.
This letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your manufacturing and quality management systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.
Please notify this office in writing within fifteen (15) business days from the date you receive this letter of the specific steps you have taken to correct the noted violations, as well as an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions you have taken. If your planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of these activities. If corrections and/or corrective actions cannot be completed within 15 business days, state the reason for the delay and the time within which these activities will be completed. Your response should be comprehensive and address all violations included in this Warning Letter.
Your response should be sent to Patrick L. Wisor, Compliance Officer, U.S. Food and Drug Administration, Kansas City District Office, 11630 West 80th Street, Lenexa, KS 66214.
John W. Thorsky
Kansas City District Office