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Focus Laboratories, Inc ***** Department of Health and Human Services Public Health Service Food and Drug Administration Dallas District 4040 North Central Expressway Dallas, Texas ***** 2012-DAL-WL-006 WARNING LETTER UPS OVERNIGHT MAIL RETURN RECEIPT REQUESTED November 16, 2011 Mr. Brad C. Winfrey Chief Executive Officer Focus Laboratories, Inc. 7645 Counts Massie Rd North Little Rock, AR ***** Product:Freshkote® Sterile Ophthalmic Solution, containing 2% polyvinyl pyrrolidone, 0.9% polyvinyl alcohol, and 1.8% polyvinyl alcohol. Dear Mr. Winfrey: We are writing in reference to your firm's distribution of an unapproved new drug in violation of the Federal Food, Drug, and Cosmetic Act (the Act). Based on the information your firm submitted to FDA's Drug Registration and Listing System, you distribute prescription Freshkote® Sterile Ophthalmic Solution containing 2% polyvinyl pyrrolidone, 0.9% polyvinyl alcohol, and 1.8% polyvinyl alcohol. As labeled, this product is a drug within the meaning of section 201(g)(1)(B) and (C) of the Act [21 U.S.C. §§ 321(g)(1)(B) and (C)] because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and intended to affect the structure or any function of the body of man or other animals. Further, this drug product is a "new drug" within the meaning of section 201(p) of the Act [21 U.S.C. § 321(p)] because it is not generally recognized as safe and effective for its labeled uses. Under sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d) and 355(a)], a new drug may not be introduced or delivered for introduction into interstate commerce unless it is the subject of an application approved by FDA under either section 505(b) or (j) of the Act [21 U.S.C. § 355(b) or (j)]. There is no FDA-approved application on file for the above drug product. Distributing this product or any other new drugs without an approved application therefore violates these provisions of the Act. Additionally, because the above product is a prescription drug within the meaning of section 503(b)(1) of the Act [21 U.S.C. 353(b)(1)], adequate directions cannot be written so that a layman can use this product safely for its intended uses. See 21 C.F.R. § ***** Consequently, its labeling fails to bear adequate directions for its intended uses, causing it to be misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. Because your product lacks a required approved application, it is not exempt under 21 C.F.R. § ***** from the requirements of section 502(f)(1) of the Act. The introduction or delivery for introduction into interstate commerce of this product therefore violates section 301(a) of the Act [21 U.S.C. § 331(a)]. Consistent with its "Marketed Unapproved Drugs - Compliance Policy Guide," 1 FDA does not intend to initiate enforcement action related to Freshkote® Sterile Ophthalmic Solution, unless the manufacturing of this product continues more than 90 days after the date of this letter. Furthermore, FDA does not intend to initiate enforcement action related to the shipment in interstate commerce of this product unless it is still being distributed more than 180 days after the date of this letter. You should be aware that FDA's enforcement discretion will not apply if (1) FDA determines that your firm is violating other provisions of the Act; (2) it appears that your firm, in response to this letter, increases its manufacture or distribution of Freshkote® Sterile Ophthalmic Solution above your usual volume during these periods; or (3) FDA learns of new information regarding any serious health risk or hazard associated with this drug product. The violations cited in this letter are not necessarily limited to Freshkote® Sterile Ophthalmic Solution and may apply to all drug products that you distribute without FDA-approved applications. You are responsible for (1) investigating and determining the causes of the violations identified above; (2) preventing their recurrence or the occurrence of other violations; and (3) assuring that your firm complies with all requirements of Federal law and FDA regulations. You should take prompt action to correct the violations cited in this letter. Within fifteen (15) working days of receipt of this letter, please notify this office in writing of your plan to cease the violative activities described in this letter. Indicate: • whether you no longer distribute the product referenced in this letter; • the reasons for, and the date on which, you ceased distribution; • the name and address of any other manufacturer or supplier of these products; and • your progress updating FDA's Drug Registration and Listing System in accordance with 21 C.F.R. 207.30(a)(2). See ***** Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction. Other Federal agencies may take this Warning Letter into account when awarding contracts. Direct your response to Seri L. Essary, Compliance Officer, FDA Dallas District Office, 4040 N. Central Expressway, Suite 300, Dallas, TX ***** If you have any questions regarding any issues in this letter Ms. Essary may be reached at ***** Sincerely, /S/ Reynaldo R. Rodriguez, District Director 1 Marketed Unapproved Drugs—Compliance Policy Guide. Available at *****