Inspections, Compliance, Enforcement, and Criminal Investigations
Care Products Inc 10-Jul-06
Department of Health and Human Services
Public Health Service
July 10, 2006
RETURNED RECEIPT REQUESTED
Mr. Charles L. Graham, President and Owner
Care Products, Inc.
P.O. Box 720193
McAflen, Texas 78504
Dear Mr. Graham:
Between June 12 and 16, 2006, the United States Food and Drug Administration (FDA) conducted an inspection of your establishment located at 10701 North Ware Road, McAilen, Texas 78504. The FDA investigators determined that your firm manufactures and distributes shower gumeys/wheeled stretchers, shower chairs, manual mechanical walkers and chairs, and low resident (safety) beds that are used primarily in long-term care facilities for residents or patients with disabilities . These products are devices, as defined by section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C.§ 321(h)).
The FDA's inspection revealed that 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 the manufacturing, packing, storage, or installation are not in conformance with the Current Good .Manufacturing Practice (CGMP) requirements of the Quality System (QS) Regulation for medical devices, as specified in Title 21, Code of Federal Regulations (CFR), Part 820. Your devices are also misbranded within the meaning of Section 502(t)(2) of the *Act (21 U.S.C. § ~352(t)(2)) because your firm failed to (a) submit a report of a medical adverse event to FDA; and (b) establish and maintain adequate written medical device reporting (MDR) procedures, as required by Section 519 of the Act (21 U.S.C. § 360i) and the MDR Regulation, 21 CFR Part 803.
At the close of the inspection, FDA issued to you a list of Inspectional Observations, Form FDA-483, which .identifies a number of significant violations, including, but not limited to, those described below.
On July 3 and 5, 2006, the FDA's Dallas District Office received your response letters, dated June 29, 2006, and June 19, 2006, respectively, responding to the investigators' observations noted on the FDA-483. You acknowledged your fikm's deficiencies in the implementation of FDA's requirements with regard to certain medical device manufacturing processes and promised general corrective actions. We have reviewed your response letters and concluded that they were not adequate in that you have not expressed and implemented a corrective action plan which requires specific actions with expected timeframe(s) you will take to correct the- deficiencies noted on the FDA483 and this warning letter.
1. Failure to establish and maintain adequate complaint handling procedures for receiving, reviewing, evaluating, and documenting complaints by a formally designated unit, as required by 21 CFR § 820.198(a), and failure to ensure that all the requirements of 21 CFR §.820.198(a) through (e) are met. FDA-483 Item 3. For example, your firm failed to:
a. Establish any written complaint handling procedures.
b. Maintain records of complaints your firm received in the past 8 years. You stated to the FDA investigators that in January or February, 2006, your firm lost its entire electronic complaint database due to a computer hardware failure. Your firm failed to maintain back-up procedures for saving or restoring electronic complaint records.
c. Use a complaint form to document sources of information which reported a femur fracture injury of a nursing home patient as a result of her fall from your firm's Model 740 shower gurney. Examples of the sources of complaint information your firm received include a certified letter from the insurance company of the nursing home, dated April 26, 2006, a certified letter froni your firm's distributor, dated May, 11, 2006, and a series' of e-mail correspondence between your firm and its distributor, dated between May 2 and 15, 2006.
d. Document appropriate justification for not reporting the complaint of a femur fracture injury to FDA and not maintaining any complaint that represents a MDR reportable event in a separate portion of the complaint file, or otherwise clearly identified.
2. Failure to analyze processes, work operations, concessions, quality audit reports, service records, complaints, returned products, and other sources of quality data to identify existing and potential *causes of nonconforming product, or other quality problems, as required by 21 CFR § 820.100(a)(1), and failure to document the results of corrective action, as required by 21 CFR § 820.100(b). FDA-483 Items 3 and 4. Because your firm lost its entire electronic complaint records and lacked adequate design change records, your firm may . not have the necessary documented and reliable quality data for its analysis in order to identify potential quality problems in your shower gumeys or the other products.
3. Failure to establish and maintain adequate 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 4. Your firm failed to establish. written procedures for reviewing, documenting, validating or testing, and approving design change(s) for your shower gurneys/Wheeled stretchers. Additionally, you stated to the FDA investigators that immediately following the notification of the resident injury involving your Model 740 Shower Gurney, on May 2, 2006 your Vice President of Production verbally instructed your employees to implement a design change to the locking mechanism of the side rails (from the [redacted] design to the [redacted] design) to manufacture new production Model 740/750 shower gurneys. Your Vice President of Production later clarified that the same design was already being used in other similar Model 700 L and C shower gurneys and was used to make the locks stronger. Although the design change may or may not have directly related-to the complaint of a patient. fall injury, your firm. had not documented the design chan e until the FDA
investigators asked you. Your firm then documented its use [redacted] of the design on June 14, 2006, during the inspection. Although your firmdocumented that the design change was made to lessen the chance of the unit being pulled down accidentally and that your firm conducted a manual test of the [redacted] design; it did not document the test protocol and~.the results of the manual test.
4. Failure to establish and maintain procedures, including inspections, tests, or verification activities, for acceptance of incoming product, and for documenting the results of acceptance or rejection, as required 21 CFR § 820.80(b) . FDA-483 Item 5. For example, your firm failed to maintain records for acceptance testing or visual examination of incoming PVC pipes and fittings which are used to manufacture the above-referenced devices.
5. Failure to establish and maintain procedures to control product. that does not conform to specified requirements, including the identification, documentation, evaluation, and disposition of nonconforming product, as required by 21 CFR § 820.90(a). FDA-483 Item 6. For example, your firm has not established written procedures for evaluating nonconforming product and documenting the disposition of nonconforming product found during manufacturing or returned by customers (e.g. mechanical walkers, shower gurneys).
6. Failure to establish arid 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 wi.th the device master record, as required by 21 CFR § 820.184. FDA-483 Item 7. For example, your firm has not maintained device history records that include acceptance rec&ds~and copies of the primary identification label and labeling used for shower gurneys and mechanical walkers.
7. Failure to, establish and maintain procedures for quality audits and to conduct such audits to assure that your firm's quality syst em is incompliance with the established quality system requirements, as required by 21 CFR § 820.22. FDA-483 Item 8. For example, your firm failed to establish written procedures for: (a) conducting quality audits of all areas of your firm's quality. system within a twelve-month time frame; (b) documenting the results of each quality audit or reaudit; (c) initiating corrective action as a result of each quality audit when necessary; and (d) providing a report of the audit results to management with responsibility for the matters being audited.
Medical Device Reporting Regulation
Additionally, the above-stated inspection revealed that your devices are misbranded under Section 502(t)(2) of the Act, in that your firm failed or refused to fumish material or
information required by or under Section 519 respecting the device . Specifically,
1. Your firm failed to develop, maintain, and implement written medical device reporting (MDR) procedures, as required by 21 CFR § 803.17, and failed to maintain an MDR event file. for each medical adverse event, as required by 21 CFR § 803.18. See FDA 483 Item 2.
2. Your firm failed to submit an MDR within 30 days of receiving or otherwise becoming aware of inforrnation that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury, as required by 21 USC § 360i(a) and 21 CFR § 803.50(a)(9). FDA-483 Items 1 and 3. Your .frrm manufactured and delivered a Model 740 Shower gurney to the subject nursing home on or around November 8, 2005. In a certified letter dated April 26, 2006, the insurance company of the nursing home notified your firm and your distributor that a resident patient fell from' this shower gurney and sustained a femur fracture on December 27, 2005. The insurance company investigated the incident and' concluded that the locking mechanism on the right side rail of the subject shower gurney likely failed and that the resident patient rolled off the gurney and onto the floor. The side rail is to prevent a patient fall, and the locking mechanism is to prevent the side rail from dropping. You reportedly received the insurance company's certified letter about the incident on May 2, 2006 . Additionally, your distributor informed . your firm of the patient injury in an e-mail, dated May 2, 2006, and a follow-up letter, dated May 11, 2006. Your firm exchanged e-mail correspondence with the distributor to help obtain additional information about the incident between May 2 and May 15, 2006. The FDA recognizes that your firm tried to obtain additional information regarding the use of your product and the circumstances of the patient fall through your distributor and your own insurance company, but emphasizes that your firm cannot delay reporting the medical adverse event to FDA. Regardless of whether the fall was due to a potential user error in letting the side rail down, a potential defective locking mechanism, or a potential design weakness in the locking mechanism, your firm should have submitted an initial MDR injury report to FDA by June 2, 2006, within 30 days of first becoming aware of the medical adverse event. After your firm submits an initial MDR report and obtains additional investigative information to determine whether the locking mechanism failure was apparent or inconclusive, or a user error resulted in the injury, your firm must submit a supplemental MDR report to FDA to update the information reported in an initial MDR report. At the conclusion of the FDA's inspection on June 16, 2006, your firm still had not submitted any MDR report to FDA.
On July 5, 2006, the FDA's Dallas District Office received your unsigned letter, dated June 19, 2006, attaching a copy of the 'initial MDR report. (Medwatch Form 3500A). Your firm mailed the original copy of the initial MDR report to the FDA's CDRH/OSB after the conclusion of the FDA's June 16, 2006, inspection. Upon the CDRH/OSB's receipt and review of your initial MDR report, you may be asked to provide additional information for their review. You are reminded that failure to provide additional MDR information requested by FDA will cause your devices to be misbranded under Section 502(t)(2) of the Act. Additionally, your firm's MDR event file must maintain a copy of the initial and supplemental MDR report and other supporting records your firm possesses, both written and electronic, and the results of your firm's MDR investigation must be adequately deliberated, documented, and maintained in your firm's MDR event file in accordance with the requirements of 21 CFR § 803.18.
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 requirement of the Act and the regulations. The specific violations noted in this letter and in the Form FDA-483 may be symptomatic of other serious underlying problems in your firm's manufacturing and quality assurance systems.
You must take immediate action to correct all violations of the Act and FDA regulations. Failure to promptly correct your firm's violations may result in regulatory action being
initiated by the FDA without further notice. These actions include, but are not limited to, seizuie, injunction, and/or civil penalties.
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 applications for premarket approval to which the QS 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. 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 timeframes 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 violatlons will not recur.
Your response should be sent to Thao Ta, Compliance Officer, Food and Drug Administration, HFR-SW140, 4040 N. Central Expressway, Suite 300, Dallas, TX 75240. If you have any questions about the contents of this letter, please contact Mr. Ta at 214- 253-5217.
Michael A. Chappell
Dallas District Director