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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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IsoComforter Inc 15-Apr-04

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

Public Health Service
Food and Drug Administration


555 Winderley Pl., Ste. 200
Maitland, Fl 32751




April 15, 2004

Paul J. Golden, Owner
IsoComforter, Inc.
3531 SW Corporate Parkway
Palm City, Florida 34990

Dear Mr. Golden:

On January 5, 6 and 9, 2004, an investigator from the Food and Drug Administration (FDA) conducted an inspection of your facility, which manufactures a cold therapy unit intended for the treatment of soft-tissue injuries and post-surgical recovery and rehabilitation. These products are medical devices under the Federal Food, Drug, and Cosmetic Act (the Act), because they are intended for use in diagnosing or treating a medical condition or to affect the structure or a function of the body within the meaning of section 201(h) of the Act (21 U.S.C. 321(h)).

The inspection revealed that your medical 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 set forth in FDA's Quality System (QS) Regulation, codified in Title 21 of the Code of Federal Regulations, Part 820 (21 CFR Part 820). The inspector noted the following QS Regulation violations, which are also listed in the FDA Form 483 provided to your facility at the end of the inspection:

1. Management with executive responsibility failed to establish its policy and objectives for, and commitment to, quality and failed to ensure that the quality policy is understood, implemented, and maintained at all levels of the organization, as required by 21 CFR 820.20. You have failed to establish key components of a quality system, including a quality control unit, a quality policy, and written quality control procedures, and no internal quality audits have been conducted (FDA 483, Item #1).

2. Your firm failed to validate with a high degree of assurance and approve according to established procedures a process whose results cannot be fully verified by subsequent inspection and test, as required by 21, CFR 820.75(a). The sterilization process conducted by [redacted] was not fully validated and approved prior to implementation (FDA 483, Item #8).

3. Your firm failed to establish and maintain procedures for implementing corrective and preventive action (CAPA), as required by 21 CFR 820.100.(a). Your firm has not established any CAPA procedures (FDA 483, Item-#3)

4. Your firm failed to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50. Specifically, your firm has not established the quality requirements that must be met by suppliers, contractors, and consultants, and has not evaluated potential suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements. For example, you have not audited [redacted] your contract sterilizer, or other suppliers of components (FDA 483, Item #7).

5. Your firm failed to develop, conduct, control and monitor production processes to ensure that your device conforms to specifications, as required by 21 CFR 820.70(a). Specifically, although process controls are needed to ensure conformance to specifications, your firm failed to establish and maintain process control procedures that include documented instructions, standard operating procedures, and methods that define and control the manner of production (FDA 483, Item #5).

6. Your firm failed to document acceptance activities, as required by 21 CFR 820.80(e). Specifically, your firm failed to document the acceptance activities performed for finished devices or incoming product (e.g., sterilized pads) (FDA 483, Item #6).

7. Your firm failed to establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(i). Several changes to the CryoTech 100 were made without validation and approval prior to implementation (FDA 483, Item #4).

8. Your firm failed to: (1) have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by the QS Regulation are correctly performed; (2) establish procedures for identifying training needs; (3) ensure that all personnel are trained to adequately perform their assigned responsibilities; and (4) document such training, as required by 21 CFR 820.25. Specifically, your firm has not conducted QS Regulation training and has not documented job-related training (FDA 483, Item #2).

You should take prompt action to correct these deviations. Failure to do so 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 penalties. Additionally, no premarket submissions for Class III devices to which QS Regulation deficiencies are reasonably related will be cleared until the violations have been corrected. Also, no requests for Certificates for Products for Export will be approved until the violations related to the subject devices have been corrected. 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.

We have reviewed your response dated January 16, 2004 and find that it adequately addresses most of our concerns. However, your response does not provide documentation showing that corrective actions have been implemented in the areas of CAPA, design controls, training, incoming and finished product testing and acceptance, audits of suppliers and contractors, and validation of the sterilization system. Please provide this information when it becomes available. Your response should be sent to Timothy J. Couzins, Compliance Officer, Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland, Florida 32751, (407) 475-4728. Following our receipt and review of this documentation, we will reschedule your facility for inspection to verify your promised corrective actions.

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 regulations.



Emma Singleton
Director, Florida District

cc: Eric Sesack, President
Isocomforter, Inc.
3531 S.W. Corporate Parkway
Palm City, Florida 34990