Inspections, Compliance, Enforcement, and Criminal Investigations
Healthline Medical Products Inc 31-May-07
Department of Health and Human Services
Public Health Service
555 Winderley PI., Ste. 200
RETURN RECEIPT REQUESTED
May 31, 2007
James Magnuson, Vice President
Healthline Medical Products, Inc.
1065 East Story Road
Winter Garden, Florida 34787
Dear Mr. Magnuson:
During an inspection of your firm located at the above address on February 13-15, 2007, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures several types of medical devices including transport shower gurneys (adult and pediatric), manual wheelchairs, shower/commode chairs, and walkers. 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.
This 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.
These violations include, but are not limited to, the following:
> Your firm failed to ensure that an adequate and effective quality system with oversight by management with executive responsibility has been fully implemented and maintained at all levels of your organization as required by 21 CFR 820.20. Your firm has not established, implemented and maintained an effective quality system at all levels of your organization including a Corrective and Preventive Action (CAPA) procedure, an Internal Audit procedure, a Management Review procedure, a Quality Policy, and a Quality Plan that defines quality practices, resources and activities.
o Your firm has not established written procedures for management review at appropriate intervals to ensure that the quality system satisfies the requirements of the QSR and the established quality policy and objectives of your firm, as required by 21 CFR 820.20(c).
> Your firm has not established and implemented written procedures for the following:
o Device history records are not maintained and written procedures have not been developed that ensure that device history records (DHRs) for each batch, lot or unit are maintained to demonstrate that the device was manufactured in accordance with the device master record (DMR) and the Quality System regulations, as required by 21 CFR 820.184.
o Your firm failed to maintain device master records (DMRs) that include or refer to the location of device specifications as required by 21 CFR 820.181(a). For example, your firm lacks device master record including but not limited to a full list of materials and diagrams of finished devices with specifications or procedures covering in-house manufacturing processes such as gluing or inspections of its medical devices.
o Your firm failed to formally designated unit for complaint evaluation to maintain records of investigations conducted under 21 CFR 820.198, as required by 21 CFR 820.198(e).
o Your firm failed to establish and conduct quality audits to verify that your quality system is effective and in compliance with an established quality system, as required by 21 CFR 820.22.
o Your firm has not established procedures to control the design process, as required by 21 CFR 820.30(a).
o Your firm has not established procedures for implementing corrective and preventive actions, as required by 21 CFR 820.100(a).
> Your firm failed to establish and maintain the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants, as required by 21 CFR 820.50(a). For example, your firm uses several contractors and suppliers and none have been evaluated.
Our inspection also revealed that your 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:
Failure to submit an MDR report within 30 days of receiving or otherwise becoming aware of information that reasonably suggested that a marketed device may have caused or contributed to a serious injury as required by 21 CFR 803.50(a)(1).
Failure to develop written MDR procedures, as required by 21 CFR 803.17.
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 FDA 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 Brant M. Schroeder, Compliance Officer, Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland, Florida 32751, (407)475-4763.
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.
Emma R. Singleton
Director, Florida District