Inspections, Compliance, Enforcement, and Criminal Investigations
Freeman Manufacturing Company Corporation
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
300 River Place
Detroit, MI 48207
December 9, 2009
VIA FEDERAL EXPRESS
Mr. Thomas Rock
Freeman Manufacturing Company Corporation
900 West Chicago Road
Sturgis, Michigan 49091-9701
Dear Mr. Rock:
During an inspection of your firm located in Sturgis, Michigan on September 2, 2009 through September 4, 2009, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures VENA-FLO® USA 2030/3040 Medical Compression Stockings, VENA-FLO® ANTI-EMBOLISM STOCKINGS and VENA-FLO®Fashion 20 Medical Support Stockings, 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,
A review of your product labeling for the VENA-FLO® USA 2030/3040 Medical Compression Stocking reveals that you are promoting these products for the use in "heaviness and fatigue in the leg, mild varicosities without clear tendency to edema, mild varices during pregnancy, combined arterial and venous insufficiency" and "relief of aching, heaviness and fatigue due to varices; prophylaxis and treatment of severe varices with tendency to edema, after sclerotherapy or varicotomy; severe varices during pregnancy; pregnant patients with previous phlebitis; postphlebitic syndrome with chronic venous insufficiency; stasis dermatitis due to chronic venous insufficiency, and control of edema and scarring after burns,"
A review of your product labeling for the VENO-FLO® ANTI-EMBOLISM STOCKINGS reveals that you are promoting these products to "aid venous blood flow to reduce risk of thrombosis for the recumbent patient" and to "reduce the risk of clot formation in the legs," Your labeling says, "During periods of prolonged bed rest, leg muscles are inactive causing venous blood flow to be slower that normal. With reduced blood circulation in the legs, the risk of blood clot formation increases, To guard against such risk, ANTI-EMBOLISM Stockings are prescribed to promote increased blood flow velocity," In addition, your labeling indicates that this product is contraindicated in patients with the following conditions: dermatitis; immediate postoperative vein ligation; gangrene; recent skin graft or any other local leg condition that stockings would impede; severe arteriosclerosis or other ischemic vascular disease; massive edema or pulmonary edema from congestive heart failure; extreme leg deformity; and patients with upper thigh circumference greater than 25 inches (when using thigh length stockings),"
A review of your product labeling for the VENO-FLO® Fashion 20 Medical Support Stockings reveals that you are promoting these products for use in "edema or slight varicosity," In addition, your labeling indicates that these products are not to be used when conditions include, "Ischemia; eczema; dermatitis; acute ulceration; arteriopathies; serious arterial diseases; varicothrombosis,"
Additionally, the product labeling for the VENA-FLO® USA 2030/3040 Medical Compression Stockings and VENA-FLO® ANTI-EMBOLISM STOCKINGS state that the hosiery have a "special feature that changes the aqueous character of nylon and makes it as soft, cool and comfortable as natural fiber, Its anti-microbial capability helps prevent the growth of bacteria and fungus, which stimulate foot odor and athlete's foot."
Our inspection revealed that the VENA-FLO® USA 2030/3040 Medical Compression Stockings, VENA-FLO® ANTI-EMBOLISM STOCKINGS and VENA-FLO® Fashion 20 Medical Support Stockings are adulterated under section 501(f)(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 an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g). The devices are also misbranded under section 502(0) the Act, 21 U.S.C. 352(0), because you did not notify the agency of your intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. 360(k). For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. 360(k), is deemed satisfied when a PMA is pending before the agency, 21 C.F.R. 807.81(b). The kind of information you need to submit in order to obtain approval or clearance for your device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.
At the conclusion of this inspection, there was no Form FDA 483 issued. However, the Establishment Inspection Report (EIR) documented evidence of a deficiency of the Quality System (QS) regulation, 21 CFR 820. While some nonconforming practices or conditions were observed during the inspection, they do not appear to warrant consideration of regulatory follow-up at this time.
Your firm failed to adequately establish procedures for quality audits and to conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system, as required by 21 CFR 820.22. For example, section 5.6 of your firm's procedure for Internal Quality Auditing, Document number 17P001, Revision A, 7/7/98 states, "each area of the Quality System is audited, at a minimum, annually." However, your firm has not performed any internal quality audits since the previous inspection in July 2007.
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. 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 LCDR Anastasia M. Piliafas-Brown, Compliance Officer, U.S. Food and Drug Administration, 300 River Place, Suite 5900, Detroit, MI 48207. If you have any questions about the content of this letter, please contact LCDR Piliafas-Brown at (313) 393-8270.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violation(s) at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violation(s) noted in this letter 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.
Joaffil M. Givens
Detroit District Office