Inspections, Compliance, Enforcement, and Criminal Investigations
MJM International Corporation 21-Jul-05
Department of Health and Human Services
Public Health Service
July 21, 2005
RETURNED RECEIPT REQUESTED
Mr. Gilbert Moroles, President
MJM International Corporation
2003 North I Road, Ste 10
San Juan, TX 78589-3206
Dear Mr. Moroles:
On February 8 through 11, 2005, the United States Food and Drug Administration (FDA) conducted an inspection of MJM International Corporation, located in San Juan, Texas. Your firm manufactures mechanical walkers, shower and transfer wheeled chairs, shower gurneys/wheeled stretchers, and low (safety) beds that are used primarily in long-term care facilities and hospitals for residents or patients with disabilities. These products are medical devices as defined in Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 321(h)).
The above referenced inspection documented violations of the Current Good Manufacturing Practice (CGMP) of the Quality System regulation (Title 21, Code of Federal Regulations (21 CFR) Part 820). FDA also learned that your firm is marketing the "400 Series" Mechanical Walkers made from polyvinyl chloride and the Model 418-24 Combination Walker/Wheelchair without approval or clearance from FDA in violation of the Act. We also found violations of the Medical Device Reporting regulation (21 CFR Part 803). The inspection also revealed that your firm has not adequately completed establishment registration and device listing according to the relevant FDA regulations (21 CFR Part 807). Each of these violations as well as information regarding establishment registration and device listing is discussed below.
Quality System Regulation
The FDA inspection revealed that your devices are adulterated and misbranded within the meaning of the Act. Your devices are adulterated within the meaning of Section 501(h) of the Act (21 U.S.C. 351(h)) because the methods used in, or the facilities or controls used for their manufacturing; packing, storage, or installation are not in conformance with the CGMP requirements of the Quality System (QS) Regulation for medical devices, as specified in 21 CFR Part 820.
At the close of the inspection, your firm was issued a List of Inspectional Observations, Form FDA-483 (copy enclosed), which identified a number of significant QS Regulation violations including, but not limited to, those described below. Some of these observations are repeat observations from- the previous August 2004 inspection.
1. Failure of the management with executive responsibility to ensure that an adequate and effective quality system has been fully implemented and maintained at all levels of the organization, as required by 21 CFR 820.20 [FDA-483 Items 1 through 10].
2. Failure to allocate adequate resources, including the assignment of trained personnel for management, performance of work, and assessment activities, as required by 21 CFR 820.20(b)(2). Your firm does not allocate necessary resources to ensure that your firm's management obtains the necessary training in order to understand and implement the Quality System Regulation requirements or seeks help from a quality -system consultant to provide training and/or develop adequate quality system procedures. At the conclusion of our previous August 2004 inspection, your firm indicated to our investigator that your firm downloaded the general requirements of 21 CFR
820 - QS regulation from the FDA's website and would use them "as is." Your firm failed to modify and format the general QS regulation requirements into detailed procedures to reflect your firm's actual production operations and quality control practices for your-devices.
3. Failure to establish and maintain adequate complaint handling procedures for receiving, reviewing, and evaluating complaints by a formally designated unit and to ensure that all the requirements of 21 CFR 820.198(a) through (e) are met [FDA-483 Item 3]. This repeats our observation from the previous August 2004 inspection. For example:
a) Your current complaint handling procedure titled "Incident Reporting," dated November 2, 2004, does not specify all the required complaint information to be documented upon your firm's receipt of each complaint. For example, there is no field for recording the nature and details of the complaint, patient involvement, the device name, the date the complaint was received, any device identification or control number used, the name, address, and phone number of the complainant, the dates and results of investigation, corrective action taken, and any reply to the complainant; and
b) Records of 23 complaints reviewed lacked documentation of the details and nature of the complaints, the results of your firm's investigations or rationales to justify whether or not investigations were necessary, any follow-up with the users, and any corrective action taken. A number of these complaints involved device breakage. Your firm verbally alleged that these device breaks were due to freight damage and replacement products were sent. However, the actual details and the nature of how and why these devices broke were not documented; and
c) Regarding information of a potential medical adverse event your firm received in April 2003 concerning the death of a nursing home resident using your Model 418-OR-4 mechanical walker, your firm failed to promptly investigate the event and document the results of your firm's investigation and conclusion regarding the event root cause in order to determine if this potential adverse event was reportable or not reportable to FDA. See related FDA-483 Item 1.
4. Failure to establish and maintain procedures to control product that does not conform to specified requirements and to address the identification, documentation, evaluation, segregation, and disposition of nonconforming product, as required by 21 CFR 820.90(a) [FDA-483 Item 10]. For example:
a) Disposition of customer product returns was not documented;
b) Review of an August 6, 2004 credit memo indicated that [redacted] PVC pipes that "failed heat test" and [redacted] pipes (White Tee and White 4-way) that had "too tight fitting " were returned to your supplier, and a credit discount was given for other PCV pipes (White Tee and White 4-way) that had tight fitting. Your firm had no records of disposition justifying and approving your use of these [redacted] tight-fitting' pipes for manufacturing and had no records of investigation determining the root cause of [redacted] pipes that "failed heat test." Your firm has not defined acceptance or rejection criteria for pipes with "tight fitting" or "too tight fitting ." We note that in a February 8, 2005 letter from your supplier to your firm, the supplier mentioned that too tight of a fit could cause fractures and too loose of a fit could compromise the connection.
5. Failure to establish and maintain procedures for implementing corrective and preventive actions, as required by 21 CFR 820.100(a)(1) through (a)(7), and to include documentation of the results of corrective and preventive action activities, as required by 21 CFR 820.'t00(b) [FDA-483 Item 4] - a repeat observation from the previous August 2004 inspection. The current inspection documented that your firm had no corrective and preventive action procedures at all.
6. Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, and to include evaluation of suppliers, contractors, and consultants, as required by 21 CFR 820.50 [FDA-483 Item 6] - a repeat observation from the August 2004 inspection. For example:
a) Your firm has not defined, documented, and approved specifications and quality requirements for the purchased PVC pipes; and
b) Your firm has not established adequate purchasing control procedures for defining quality requirements, creating records that document or reference quality requirements, selecting potential suppliers, evaluating or auditing suppliers on the basis of their ability to meet your quality requirements, documenting the results of supplier evaluation, or creating a list of acceptable or not acceptable suppliers.
7. Failure to establish and maintain procedures for acceptance or rejection of incoming product, and for documenting the results of acceptance or rejection, as required by 21 CFR 820.80(b) [FDA-483 Item 6]. For example, your firm's procedure titled "Receiving of raw material," dated November 2004, is inadequate in that it required a number of incoming components, including the PCV pipes, to be visually inspected for "concealed damages` without establishing the specific types of defects and specific acceptance or rejection criteria.
8. Failure to establish and maintain procedures for the identification, documentation, validation or verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(i) [FDA-483 Item 9]. For example, your firm has no design change procedures for controlling design changes for your Shower Gurneys and Wheeled Stretchers, class II medical devices subject to design controls. See 21 CFR 880.6910.
9. Failure to establish and maintain procedures to ensure that device history records 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 [FDA-483 Item 7]. For example:
a) Your firm has not established procedures specifying what kind of production data (e.g., dates of manufacture, quantity manufactured and released for distribution, device labels and device labeling, and acceptance results) is to be documented and how production data is to be recorded; and
b) Your sales orders, which your firm claimed were maintained as the device history records, do not include or refer to the dates of manufacture, quantity manufactured and released for distribution, device labels and labeling approved for use in each device, and records documenting the results of acceptance or rejection of the devices.
10. Failure to maintain device master records (DMR's) to include or refer to the location of device specifications, production process specifications, quality assurance procedures, packaging and labeling specifications, and to ensure that each DMR is prepared and approved in accordance with 21 CFR 820.40, as required by 21 CFR 820.181. For example, your firm provided to our investigator a hand drawing of the Model 910 Shower Gurney and Wheeled Stretcher during the current inspection. This drawing is inadequate as a DMR in that it shows no dimensional and tolerance specifications, a description of the legends, type of materials for this device, the date and the signature of the individual(s) approving the hand drawing.
Lack of Premarket Submission
The Act requires that manufacturers of medical devices obtain marketing clearance for certain products from the FDA before they may offer them for sale. This protects the public health by helping to ensure that newly introduced medical devices are safe and effective or substantially equivalent to other devices already legally marketed in this country.
A review of our records has determined that you have not obtained FDA marketing clearance or approval for your firm's Polyvinyl Chloride mechanical walkers, which is a violation of the law. 21 CFR 890.3825 classifies a mechanical walker as a four-legged walker made of metal and exempts the metal walker from premarket notification submission requirements. Your firm's mechanical walkers made of Polyvinyl Chloride exceed the material limitation allowed in 21 CFR 890.3825, and therefore your PVC walkers are not considered to be exempt from the premarket notification requirements of Section 510(k) of the Act. Hence, it appears that a cleared premarket notification submission (510(k) submission) is required in order to legally market these devices.
Our records also show that you have not obtained FDA marketing clearance or approval for your firm's Model 418-24 Combination WaIker/Wheelchair, which is also a violation of the law. The Model 418-24 Combination Walker/Wheelchair falls under the classification for mechanical wheelchairs (21 CFR 890.3850) based on its design and indications for use, because it has a seat, wheels and hand rims for manual propulsion. According to 21 CFR 890.3850, mechanical wheelchairs are class 1, but are not exempt from the requirements of Section 510(k) of the Act. Therefore, it appears that the Model 418-24 Combination Walker/Wheelchair requires a cleared 510(k) submission in order to be legally marketed.
Because you have not obtained FDA clearance or approval to market your PVC mechanical walkers or your Model 418-24 Combination Walker/Wheelchair, marketing of these devices is in violation of the law. In legal terms, these devices are adulterated under section 501(t)(1)(B) of the Act (21 U.S.C. 351(f)(1)(B)) because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act (21 U.S.C. 360e(a)), or an approved application for investigational device exemption (IDE) under section 520(g) of the Act (21 U.S.C. 360j(g)). These devices are also misbranded under section 502(o) of the Act (21 U.S.C. 352(o)) because you did not notify the agency of your intent to introduce the devices into commercial distribution, as required by section 510(k) of the Act (21 U.S.C. 360(k)). The kind of information you need to submit in order to obtain this clearance or approval is available through the Internet at http://www.fda.gov/cdrh/devadvice/3122 html. If you file a premarket submission, the FDA will evaluate this information and decide whether your product may be legally marketed.
Medical Device Reporting Regulation
The above-stated inspection also revealed that your devices are misbranded within the meaning of Section 502(t)(2) of the Act (21 U.S.C. 352(t)(2)) because your firm failed to submit a report of a medical adverse event within the 30-day time frame to FDA, as required by Section 519 of the Act (21 U.S.C. 360(i)) and the Medical Device Reporting (MDR) regulations set forth in 21 Code of Federal Regulations (CFR), Part 803. Specifically, you failed to file a report of death, serious injury, or malfunction to FDA within 30 calendar days from becoming aware of the reportable event, as required by 21 CFR 803.50(a) [FDA-483 Item 1]. This is a repeat observation from the August 2004 inspection. For example, at the completion of our February 2005 inspection, your firm failed to submit a MDR report for the death of a nursing home resident using your Model 418 mechanical walker which was alleged to have tipped over in April 2003. Your firm can not postpone its decision to report the event while it continues to collect additional information or further investigate the event. Therefore, your firm should have submitted a MDR report for the death event within the 30-day time frame. If subsequent information or evaluation alters your firm's decision, then a supplemental report should be submitted to update the status of the MDR report. A post-inspection review of our MDR data base indicated that your firm finally submitted the MDR manufacturer report to FDA on March 11, 2005 after our February 11, 2005 inspection and approximately two years after your firm became aware of the death event.
You also failed to develop, maintain, and implement adequate written MDR procedures, as required by 21 CFR 803.17 [FDA-483 Item 2]. For example, your procedure titled "Incident Reporting," dated November 2004 does not provide:
a) An internal system providing for timely and effective communication and evaluation of adverse events; a standardized review process and procedures for determining whether or not an event is reportable; and procedures to insure timely transmission of complete reports;
b) Documentation and record keeping requirements for MDR event files.
You also failed to maintain MDR event files, as required by 21 CFR 803.18 and failed to investigate and evaluate the cause of MDR reportable events, as required by 21 CFR 803.50(b)(2) [FDA-483 Item 2]. At the time of our February 2005 inspection, your firm had no records of investigation of the death event or documentation to support your decision regarding whether the death was or was not reportable. Although your firm relied on your insurance company to conduct a liability investigation of the death event after April 11, 2003, your firm is ultimately responsible for obtaining and documenting complete information from the user and/or your insurance company in order to make an informed decision to submit or not submit an MDR to FDA.
Establishment Registration and Device Listing
The above-stated inspection also documented that you still have not registered your facility and listed your devices with FDA to ensure compliance with Section 510 of the Act (21 U.S.C. 360) and 21 CFR Part 807. We acknowledge that your firm submitted an initial establishment registration to FDA in August 2004, and your firm submitted an establishment registration form FDA 2891 and several FDA 2892 device listing forms that we received on May 24, 2005. However, your establishment- registration and device listings can not be processed because the forms were not adequately complete. We remind you that it is your responsibility to adequately complete these forms and make the necessary corrections in a timely manner so that your establishment will be in compliance with the registration and listing requirements of the Section 510 of the Act (21 U.S.C.360).
Responding to This Letter
This letter is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure adherence to each relevant requirement of the Act and FDA regulations. The specific violations noted in this letter and in the Form FDA-483 issued at the close of the inspection may be symptomatic of other serious underlying problems in your firm's manufacturing and quality assurance systems. You are responsible for investigating and determining the causes of the violations identified by the FDA. You must also promptly initiate permanent corrective and preventive action on your quality system.
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, no premarket approval applications for Class III devices to which the Quality System regulation deficiencies are reasonably related will be approved until the violations have been corrected. Also, no requests for Certificates to Foreign Governments will be approved until the violations related to the subject devices have been corrected.
You should take prompt action to correct these violations. 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/or the initiation of procedures to impose civil penalties. Please notify this office in writing within 15 working days of receipt of this letter of the specific steps you have taken, or will take to identify and correct the noted violations, including (1) the time frames within which the corrections will be completed, (2) any documentation indicating the corrections have been achieved, and (3) an explanation of each step being taken to identify and make corrections to any underlying systems problems necessary to ensure that similar violations will not recur.
Your reply should be directed to Thao Ta, Compliance Officer, at the address indicated on the above letterhead.
Michael A. Chappell
Dallas District Director