Inspections, Compliance, Enforcement, and Criminal Investigations
Benchmark Medical, Inc. 03-Nov-06
Department of Health and Human Services
Public Health Service
Denver District Office
November 3, 2006
RETURN RECEIPT REQUESTED
Mr. Dennis K. Scott
Benchmark Medical, Inc.
466 Lawndale Dr., Suite D
Salt Lake City, UT 84115
Dear Mr. Scott:
An investigator from the U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility April 10 - 13, 2006. Based on information and labeling obtained during our inspection, your products "BENCHMARK'S Derma Shield," "BENCHMARK'S Derma Plus," and "BENCHMARK'S Derma Med" are skin protectant drugs subject to the "Skin Protectant Drug Products For Over-The-Counter Human Use" monograph which is set forth in Title 21 of the Code of Federal Regulations, Part 347 (21 C.F.R., Part 347).
The regulatory status of "BENCHMARK'S Derma Shield," "BENCHMARK'S Derma Plus," and "BENCHMARK'S Derx(a Med" as "drugs" and "new drugs" was explained previously in our April 22, 1993 Warning Letter to you and is further explained below.
Based on claims appearing on the immediate container labels for each of these products ('i.e. .,"Helps prevent and temporarily protects chafed, chapped, cracked, oz windburned skin"), they, are "drugs" as defined by Section 201(g) of the Federal Food, Drug, and Cosmetic (the Act) [21 U.S.C. § 321(g)]. Moreover, they are subject to the final monograph covering skin protectant drug products for over-the-counter (OTC) human use [21 C.F.R., Part 347]. However, in addition to these claims, promotional brochures, which you provide to your customers, include statements claiming that, when applied to the skin, these products provide an effective barrier that is unaffected by repeated hand washing. Statements on this promotional labeling also claim that these products remain effective for up to four hours to prevent the adverse consequences caused by contact with : chemicals of all kinds, including acids and alkalis; organic and inorganic substances of all kinds ; and all pathogenic microorganisms. Such statements include:
". . . becomes an invisible protectant that actually bonds to the skin and helps protect it . . . prevents harmful substances from penetrating the skin and entering the bloodstream . . . it will protect your skin from both acids and alkalis, as well as organic and inorganic substances . . . doesn't wash off even with repeated washings . . . lasts between 4-8 hours . . . prevents harsh solvents and chemicals from coming in contact with the skin . . . prevent caustic burns and industrial dermatitis . . . an effective and reliable second line of defense [under gloves] . . . will protect the skin in case of defective gloves . . . protection against viruses and many bacteria . . . ."
These skin barrier claims are "drug" claims as defined by Section 201(g) of the Act [21 U.S.C.§ 321(g)]. The final monograph for OTC skin protectants, referenced above, permits none of these claims. See 21 C.F.R. § 347.50(b)(2). During the April 2006 inspection of your firm, you acknowledged that "BENCHMARK'S Derma Shield," "BENCHMARK'S Derma Plus," and"BENCHMARK'S Derma Med" are intended for these skin barrier uses. We are not aware of any evidence establishing that these products are generally recognized as safe and effective for these uses. Therefore, they are "new drugs" under Section 201(p) of the Act [21 U.S.C. § 321(p)]. Since there is no approved new drug application (NDA) for any of these products, their marketing in the United States violates Section 505(a) of the Act [21 U.S.C. § 355(a)].
These intended skin barrier uses are further described in United States (U .S.) Patent No. 5,208,013, which is identified on the immediate container labels for these products. And U.S. patents are readily available to consumers through the Internet web site maintained by the U.S. Patent and Trademark Office (www.uspto.gov).
Further, "BENCHMARK'S Derma Shield," "BENCHMARK'S Derma Plus," and"BENCHMARK'S Derma Med" are misbranded under section 502(c) of the Act, [21 U.S.C.§ 352(c)] in that the respective labeling fails to comply with the "Drug Facts" labeling requirements for OTC drug products [see 21 C.F.R. § 201.66].
FDA previously advised you, in the Warning Letter referenced above, that the OTC skin barrier claims described above cause "BENCHMARK'S Derma,Shield," "BENCHMARK'S Derma Plus," and "BENCHMARK'S Derma Med" to be unapproved new drugs. As noted 'In this current letter, FDA has not changed its position regarding these violations and, if they persist, the agency will pursue further enforcement action.
We acknowledge receipt of your Form FDA-483 response letter, dated April 21, 2006. Your response is inadequate in that it does not contain the specific steps you plan to take or documentation of the steps you have taken to address the conditions noted.
The violations described above are not meant to be all-inclusive. It is your responsibility to ensure that all drug products manufactured and distributed by your firm comply with the Act.
Federal agencies are advised of the issuance of all Warning Letters pertaining to drugs and devices so that they may take this information into account when considering the award of contracts. You must take action immediately to correct these violations. Failure to do so may
result in regulatory action without further notice, including seizure and/or injunction.
During the inspection, our investigator also observed deviations from the current Good Manufacturing Practice (CGMP) regulations for your drug products. As a manufacturer of human drugs it is your responsibility to assure your products are manufactured in conformance with current Good Manufacturing Practices as delineated in 21 CFR§ 210 and 211.
For example, your firm failed to provide an air break or other mechanical device, between the sewer and the deionized water tank, to prevent back- siphonage as required by 21 CFR § 211.48(b). Also, the water line from the deionized water tank to the product mixing kettles is constructed in such a manner that the piping allows standing water to accumulate between drug product batches. In addition, your firm failed to conduct identity testing of raw materials as required by 21 CFR § 211.84(d)(2). Furthermore, your batch records are incomplete as required by 21 CFR § 211.188 in that your in-process and laboratory results, fill lot numbers, weight of raw ingredients, and additional necessary documentation is not included in your batch records. Finally, your firm failed to develop a written testing program to test the stability characteristics of drug products which are used to determine appropriate storage conditions and expiration dates as required by 21 CFR § 211.166(a) in that your firm does not collect stability samples or test the stability of your drug products.
You must notify this office in writing within 15 working days, of receipt of this letter as to the steps that you have taken to correct the above-listed violations, and the steps taken to assure that similar violations will not recur. 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 made. Address your reply to the U.S. Food and Drug Administration, P.O. Box 25087, Denver, CO 80225-0087, Attention: William H. Sherer, Compliance Officer.
B. Belinda Collins
Denver District Director