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U.S. Department of Health and Human Services

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Enforcement Actions

AliMed Corporation 19-Aug-08

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

Public Health Service
Food and Drug Administration

 

New England District
One Montvale Avenue
Stoneham, Massachusetts 02180
(781) 596-7700
FAX: (781) 596-7896


WARNING LETTER
NWE-18-08W

VIA CERTIFIED MAIL

August 19, 2008

Mr. Julian Cherubini
President
AliMed Corporation
297 High Street
Dedham, Massachusetts 02026-2852

Dear Mr. Cherubini:

During an inspection of your firm located in Dedham, Massachusetts, on January 17 through February 6, 2008, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures and/or distributes TR2 Tamper Resistant Alarms, Early Warning E-Z Release Seatbelts, Bed Sensor Pad Systems, Sit-Straight Basic Cushions, Passive Infrared Alarms, Magnetic Pull-Cord Alarms, and Basic Alarms. 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.

The 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, the 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. These violations include, but are not limited to, the following:

1. Failure to establish and maintain procedures for implementing corrective and preventative action, as required by 21 CFR 820.100(a) and furthermore not analyzing other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems in accordance with 820.100 (a)(1).

During our inspection, your firm was unable to provide a written corrective and preventive action procedure to our investigator. The lack of corrective and preventative action procedures was also acknowledged by your management.

In addition, your [redacted] procedure does not address statistical analysis to detect recurring quality problems of complaints.

2. Failure to review and evaluate, and investigate where necessary complaints involving the possible failure of a device to meet any of its specifications, as required by 21 CFR 820.198(b).

Specifically, during the review of the complaint records, several reports were encountered involving the possible failure of a device to meet its specifications, and for which your firm decided that no investigation was necessary; the only justification provided was "not of interest."

For example:

a. A complaint was received on December 11, 2007, for a QualCare Magnetic Pull-Cord Alarm, which stated 3 alarms from the case did not work, the documented evaluation stated "DID NOT INSPECT Alarms did not work NOT OF INTEREST."
b. A complaint received on November 7, 2007, for a Sit-Straight Cushion with a TR2 alarm stated there was a short in the alarm connection to the cushion. The evaluation stated "NOT OF INTEREST DO NOT INSPECT."

3. Failure of your complaint handling procedure to ensure complaints are evaluated to determine whether the complaint represents an event which is required to be reported to FDA under part 803, Medical Device Reporting ( 21 CFR 820.198(a)(3)).

Your firm's [redacted] procedure does not require that your firm's complaints be evaluated to determine if the complaint is FDA reportable under the 21 CFR 803 Medical Device Reporting.

4. Failure to establish a policy and objectives for, and commitment to, quality and to ensure that the quality policy is understood, implemented, and maintained at all levels of the organization, as required by 21 CFR 820.20(a).

During the FDA inspection, we observed significant violations of quality system requirements, including lack of a quality policy, lack of management reviews of the quality system, and lack of a quality plan which defines the quality practices.

Specifically, your firm did not have a Quality Policy available when we inspected your firm. In addition your management acknowledged that your firm lacked Management Review procedures.

5. Failure to establish procedures for quality audits, as required by 21 CFR 820.22.

Your firm does not have any quality audit procedures in place to assure that your quality system is in compliance with the established quality system requirements and to determine the, effectiveness of the quality system.

Specifically, your management acknowledged that it does not have any procedures for Quality Audits.

6. Failure to establish and maintain procedures for acceptance of incoming product and failure to document acceptance or rejection, as required by 21 CFR 820.80(b).

Your firm does not have procedures for the acceptance of incoming product.

For example, your firm's receiving and acceptance procedure `MED-QSR-002 [redacted] states: "Upon receipt of raw goods from the loading dock. Raw goods shall be located and quantities will be verified with the put away list. Receiving label quantities will be checked. Visual inspection of goods to insure the, correct item was received and for quality." Procedure MED-QSR-002 does not establish quality criteria for visual inspection of goods to ensure incoming product is inspected, tested, or otherwise verified as conforming to specified requirements. In addition, no records of incoming inspections were available for review.

Our inspection also revealed that your patient alarm 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 deviations include, but are not limited to, the following:

1. Failure to develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17.

During our inspection, your firm was unable to provide a written medical device reporting procedure to our investigator. Your management acknowledged the lack of MDR reporting procedures.

2. Failure to report to FDA no later than 30 calendar days after the day that you received or otherwise became aware of information, from any source, that reasonably suggests that a device that you market may have caused or contributed to a death or serious injury, as required by 21 CFR 803.50(a)(1).

Your firm failed to submit an MDR report within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have cause or contributed to a death or injury.

Specifically, your firm's complaints are evaluated by a consultant to determine if they are MDR reportable. Your firm provided a report from your consultant dated December 18, 2002 of such an evaluation. In this instance a customer had filed a User Facility Report, dated November, 12, 2002, after a seatbelt alarm failed to sound, and a patient fell, suffering a fractured hip. Your consultant determined that an MDR was not required for this event and your firm did not file a report for this incident.

3. Failure to report information that is reasonably known to you, as required by 21 CFR 803.50(b)(1).

Specifically, during the review of the complaint records, several reports were encountered in which your firm decided that no investigation was necessary and the only justification provided was "not of interest."

For example:

a. A complaint was received on December 11, 2007, for a QualCare Magnetic Pull-Cord Alarm, which stated 3 alarms from the case did not work, the documented evaluation stated "DID NOT INSPECT Alarms did not work NOT OF INTEREST."

b. A complaint received on November 7, 2007, for a Sit-Straight Cushion with a TR2 alarm stated there was a short in the alarm connection to the cushion, the evaluation stated "NOT OF INTEREST DO NOT INSPECT."

Our inspection also revealed that your TR2 Alarms 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 deviations include, but are not limited to, the following:

1 . Failure to submit a written report to FDA of any correction or removal of a device to reduce a risk to health posed by the device, as required by 21 CFR 806.10(a)(1).

Your firm conducted a correction or removal of your TR2 Alarm that was initiated to reduce a risk to health posed by the device and a written report to the FDA was not submitted regarding this correction or removal.

Specifically, the slide switch on your TR2 Alarm was assembled backward and would cause the alarm to be turned off when the switch was slid to the armed position. You notified your customers in a letter dated March 29, 2007, of the problem and your firm replaced these TR2 Alarms free of charge. This was not reported to the FDA.

2. Failure to contain the following information, not required to be reported to FDA under 21 CFR 806.10, in records of corrections and removals, as required by 21 CFR 806.20(b) (1),(2), (3), and (4):
(1) The brand name, common or usual name, classification, name and product code if known, and the intended use of the device.
(2) The model, catalog, or code number of the device and the manufacturing lot or serial number of the device or other identification number.
(3) A description of the event(s) giving rise to the information reported and the corrective or removal action that has been, and is expected to be taken.
(4) Justification for not reporting the correction or removal action to FDA, which shall contain conclusions and any follow-ups, and be reviewed and evaluated by a designated person.

Specifically, your firm's recall file consists only of the notification letter and distribution lists. [redacted] and [redacted] tried to find more information in their email but were unable.

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 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 (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.

Your response should be sent to: Maren Forsyth, Food & Drug Administration, One Montvale Avenue, Fourth Floor, Stoneham, Massachusetts 02180. If you have any questions about the content of this letter please contact: Ms. Forsyth at 781 596-7769.

Finally, you should know that 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 firm's manufacturing and quality assurance 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.

Sincerely yours,

/S/

John R. Marzilli
Acting District Director
New England District