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U.S. Department of Health and Human Services

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Enforcement Actions

Omega Tech Labs., LLC 21-Oct-08

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

Public Health Service
Food and Drug Administration

 

Seattle District
Pacific Region
22201 23rd Drive SE
Bothell, WA 98021-4421

Telephone: 425-486-8788
FAX: 425-483-4996


October 21, 2008

VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED

In reply refer to Warning Letter SEA 09-02

Elizabeth L. Wamhoff, President of Manufacturing
Omega Tech Labs., LLC
5069 Alworth Street, Suite C
Boise, Idaho 83714-1408

WARNING LETTER

Dear Ms. Wamhoff:

During an inspection of your firm from January 31, 2008, through February 11, 2008, an investigator from the United States Food and Drug Administration (FDA) collected your firm's labeling and marketing information for the products "Fresh Protect Sanitizing Hand Foam" and "Fresh Protect Sanitizing Hand Lotion" (collectively, the Fresh Protect Products), [(b)(4)] "Anti-Bacterial moisturizing lotion," "Stop" for smoking deterrent use, "Motion" for anti-emetic use, and "Promise" to control appetite, all of which are manufactured and distributed by your firm. Labeling also was obtained for another anti-bacterial moisturizing lotion manufactured by your firm that contains on its label the terms "[(b)(4)]" which is the trade name of and active ingredient in a prescription drug product marketed by another company under an approved New Drug Application. At the conclusion of the inspection a List of Inspectional Observations (Form FDA-483) was issued and presented to you and Mr. Glenn Mouser, President of Research and Development.

As presently labeled and promoted, these products violate the new drug and misbranding provisions under Sections 505 and 502, respectively, of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. §§ 355 and 352), as described below. In addition, the inspection documented significant deviations from the Current Good Manufacturing Practice (CGMP) Regulations for Finished Pharmaceuticals (Title 21, Code of Federal Regulations (C.F.R.), Parts 210 and 211), as described below. Such deviations cause the Fresh Protect Products to be adulterated within the meaning of Section 501 (a)(2)(B) of the Act. 21 U.S.C. § 351 (a)(2)(B).

1. The New Drug and Misbranding Violations

A. The Fresh Protect Products Are Unapproved New Drugs and Misbranded

1. Factual Basis for-Charges Relating to Fresh Protect Products

According to the package labeling and your internet websites (www.freshprotect.com and www.omegatechlabs.com), the Fresh Protect Products are intended for over-the-counter (OTC) topical antimicrobial, antiviral, and skin protectant uses in preventing various disease conditions, for skin cell rejuvenation, to reduce skin lesions, and to remain on the skin and be effective for up to four hours.

The package labeling for the Fresh Protect Products identifies benzethonium chloride 0.2% as the sole "Active Ingredient." The following additional statements on the package labels for these products demonstrate the intended uses noted above:

Fresh Protect Sanitizing Hand [Foam or Lotion] Kills Germs In 15 Seconds Lasts For Hours ... It kills the bacteria that cause illness & infection including MRSA, VRE, C.Diff., Norovirus, Herpes, Influenza, Staph, Strep, E.Coli, P.Aeruginosa, molds, yeasts and more. Most of these are killed in 15 seconds or less with greater than 99.99% effectiveness. Fresh Protect Sanitizing Hand [Foam or Lotion] persists in its ability to kill bacteria for over four (4) hours.

Directions For Use: Simply apply a small amount of Fresh Protect Sanitizing [Foam or Lotion] to your palm and rub hands together until dry. Repeat often throughout the day.

A promotional brochure titled "Fresh Protect . . . Topical Infection Control" that accompanies the distribution of the Fresh Protect Products identifies "Benzethonium Chloride" as the sole "active ingredient" in these products. In addition, this labeling includes the following statements that further demonstrate your products' intended OTC topical antimicrobial and skin protectant uses:

FRESH PROTECT' Sanitizing Products have a significant effectiveness against common viruses. Although not the 9.99% as with the bacteria . . . they do have a relative capability of destroying viruses in 60 seconds or less. Influenza A (foam 99.99%, lotion 62.5%), Herpes Simplex 1/HF (foam 99.99%, lotion 74.99%), Norovirus 2280 (foam 37.5%, lotion 37.5%).

Kills Germs In 15 Seconds Lasts Over Four Hours

FRESH PROTECT Sanitizing Products are recommended by C.L. of Oregon . . . an Infection Control Practitioner . . . "I find (Fresh Protect) an excellent choice. One reason is the rapid germ kill that greatly reduces the time usually required for adequate hand cleansing . . . The germ barrier (anti-septic) provides a 'safety net' of germ killing . . . It also helps heal dry, cracked or irritated hands . . ." (emphasis in original).

A time kill test was performed to determine how rapidly Benzethonium Chloride based Fresh Protect Products (0.2%) kill germs. Test results indicated the products removed 99.99% of the bacteria listed below within 15 seconds with an average 5 log reduction . . . Persistence tests In Vivo shows that Fresh Protect products are 100% effective over four hours.

Bacteria*

Exposure Time

% Reduction

Enterococcus Faecalis & (VRE)

15 Seconds

>99.99 %

Escherichia Coli

15 Seconds

>99.99 %

Pseudomonas Aeruginosa

15 Seconds

>99.99 %

Clostridium Difficile Vegetative Foam is 99.99% Lotion is 91.25 %

15 Seconds

>99.99 %

Staphylococcus
Aureus & MRSA

15 Seconds

>99.99 %

* This table is excerpted from a larger table that details additional bacteria and viruses with similar exposure time and percent reduction records.

Your current websites (www.freshtprotect.com and www.omegatechlabs.com) for "Fresh Protect Sanitizing Hand Foam" and "Fresh Protect Sanitizing Hand Lotion" identify "Benzalkonium Chloride" (not benzethonium chloride) as the sole "FDA APPROVED ACTIVE INGREDIENT" in these products (emphasis in original). In addition, these websites include statements and representations that are similar to those appearing on the package and promotional labeling described above. These statements and representations, such as those that follow, further demonstrate your products' intended uses:

The antimicrobial action of Fresh Protect kills in 15 seconds compared to 60 seconds for alcohol. Fresh Protect continues protecting and killing bacteria for over four hours or wash off. . . . The more you use Fresh Protect, the more you enhance the health of your skin. Healthcare workers will notice considerable improvement in only two days of use. The burning and stinging from using alcohol based hand sanitizers are gone forever.

MOISTURIZING AND REJUVENATING TECHNOLOGY. This special technology incorporates Zinc, Copper, and Soy Protein to form a polypeptide that plumps up the skin cells to help them regain a youthful appearance. We also add Vitamin E, Aloe Vera, Jojoba Oil and Glycerin to smooth and further moisturize skin.

What is the active ingredient in Fresh Protect products? Unlike other products that use harsh alcohol to kill bacteria, Fresh Protect does not. Fresh Protect employs the use of Benzalkonium Chloride (0.13%) - an effective antimicrobial agent. Benzalkonium Chloride is a germicide belonging to the large group of germicides known as "Quats." Quats have been around for over 70 years and have an extensive history of safe use for disinfecting. In fact, you can find Benzalkonium Chloride in toothpastes, eye drops, and some cosmetics.

Is Fresh Protect FDA Approved? Fresh Protect uses an antibacterial agent that is FDA approved. Benzalkonium Chloride is recognized by FDA as GRAS, Generally Recognized As Safe.

The Fresh Protect site repeats the effectiveness test results delineated in the brochure as detailed above.

As recently as March 31, 2008, the fresh Protect website included additional statements and representations that indicated intended uses not made on the current sites. These statements and representations, such as those that follow, demonstrate intended uses of your product:

Fresh Protect Sanitizing Products . . . Protects your skin . . . kill 99.99% of germs that cause illness & infection in 15 seconds and lasts for hours . . . incorporate a special skin cell rejuvenator designed to boost skin cell rejuvenation by replenishing important elements of the skin cells . . . Fresh Protect Sanitizing Products kill germs that cause illness and infection including E-Coli, Staph, MRSA, Molds & Yeasts and more.

FDA APPROVED ACTIVE INGREDIENT: FRESH PROTECT uses an antibacterial agent (Benzalkonium Chloride) that is FDA approved . . .

[O]ur chief chemist . . . added three elements to enhance your body's prime protection organ-your skin . . . [b]y adding retinyl A, vitamin E, and that famous youth giving product from Japan, hyaluronic acid .. . to improve elasticity [and] . . . to reduce lesions . . . If you don't wash off you can expect protection to last close to eight hours . . . [If] you applied Fresh Protect to your child on the way to school, you could expect that he/she would be protected through the day whether at "germy" school, busses, or sports areas.

[The] lotion . . . stays on the skin and lasts longer. All the bacteria, even the dreaded MRSA and VRE, are killed instantly . . .

2. Fresh Protect Products are Unapproved New Drugs

The Fresh Protect Products are "drugs," as de fined by Section 201(g)(1) of the Act (21 U.S.C. § 3 21(g)(1)), because they are intended to cure, mitigate, treat, or prevent disease, and to affect the body's structures and functions. As described above, these products are intended to prevent diseases caused by infection with Staphylococcus aureus (MRSA), Vancomycin-resistant Enterococcus faecalis (VRE), Clostridium difficille (C.Diff.), Norovirus, Herpes, Influenza, Staph, Strep, and E. Coli, and P. Aeruginosa viruses. They also are intended to cure, mitigate, or treat disease and/or affect the body's structure or functions by rejuvenating skin cells and reducing skin lesions.

Further, these products are "new drugs," as defined by Section 201(p) of the Act (21 U.S.C. § 321(p)) because we are not aware of sufficient evidence to show that they are generally recognized as safe and effective (GRASE) by scientific experts in: (1) preventing the diseases caused by infection with MRSA, VRE, C.Diff., Norovirus, Herpes, and Influenza viruses, and the other microorganisms listed in the product labeling; or (2) cell rejuvenation, reducing skin lesions, and remaining on the skin and being effective for up to four hours.

Products without an approved NDA that claim to be OTC skin protectants must comply with the final monograph of the OTC Drug Review to be GRASE and not misbranded. Neither the active ingredient (benzethonium chloride) declared on the package labeling for "Fresh Protect Sanitizing Hand Foam" and "Fresh Protect Sanitizing Hand Lotion," nor the active ingredient (benzalkonium chloride) identified on your current web site (www.freshprotect.com), nor the labeling for these products, complies with the final monograph for OTC skin protectant drug products. 21 C.F.R. Part 347.

Nor do the developing monographs related to OTC health care and first aid antiseptics provide support for your claims. For your information, OTC health care antiseptics, which include antiseptic cleansers, and OTC first aid antiseptics are being evaluated under FDA's OTC Drug Review. Tentative final monographs (TFMs) for these products were published in the Federal Register in 1994 and 1991, respectively. TFM for OTC Healthcare Antiseptic Drug Products (59 Fed. Reg. 31402 (June 17, 1994)); Tentative Final Monograph (TFM) for OTC First Aid Antiseptic Drug Products (56 Fed. Reg. 33644 (July 22, 1991)). Although the labeled active ingredient in the Fresh Protect Products (i.e. benzethonium chloride) and the active ingredient identified by your current web site (www.freshnrotect.com) for these products (i.e., benza3konium chloride) are covered by these ongoing rulemakings for certain topical antimicrobial uses, the claims referenced above and the directions to apply the product and rub hands until dry, without rinsing with water, are not.

Finally, there is no presented evidence that the combination of such active ingredients, which include benzalkonium chloride and/or benzethonium chloride, and other listed ingredients, including retinyl A, vitamin E, and hyaluronic acid, was marketed for the uses described above on or before inception of FDA's OTC Drug Review.1 Nor is there evidence that these products are the subject of a final determination by FDA under Section 330.14. 21 C.F.R. § 330.14 (providing additional procedures for classifying OTC drugs as generally recognized as safe and effective and not misbranded). Upon the foregoing, the Fresh Protect Products are "new drugs" under the Act. 21 U.S.C. § 321(p).

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 an FDA-approved application is in effect for it. The Fresh Protect Products do not have approved applications and their introduction or delivery for introduction into interstate commerce violates these provisions of the Act. 21 U.S.C. §§ 331(d); 355(a).

3. The Fresh Protect Products are Misbranded.

The Fresh Protect Products also are misbranded. First, as noted above, the package, labeling for the Fresh Protect Products identifies benzethonium chloride as the sole active ingredient, while the web site for these products (www.freshprotect.com) identifies benzalkonium chloride as the sole active ingredient. Also noted above, this website describes retinyl A, vitamin E, and hyaluronic acid as "active ingredients," as defined by 21 C.F.R. § 201.66(b)(2), while two of these ingredients ("Retinyl Palmitate" or "Retinyl Palmitate Vit. A" and "Tocopheryl Acetate" or "Tocopheryl Acetate Vit. E") are specifically identified on the package labeling as "Other ingredients." Hyaluronic acid is not identified on any of the package labels for these products. The misleading nature of all of this conflicting information causes these products to be misbranded under Section 502(a) of the Act. 21 U.S.C. § 352(a).

Second, the statement "FDA APPROVED ACTIVE INGREDIENT" on the website www.freshprotect.com (emphasis in original) referring to benzalkonium chloride causes Fresh Protect Products to be misbranded under Section 502(a) of the Act, as further described in Section 201(n), because this statement is false and misleading. 21 U.S.C. §§ 352(a); 321(n). The Freshprotect website statement "Is Fresh Protect FDA Approved? Fresh Protect uses an antibacterial agent that is FDA approved. Benzalkonium Chloride is recognized by FDA as GRAS, Generally Recognized As Safe" similarly is false and misleading. Contrary to these statements, benzalkonium chloride has not been approved by FDA for use as a topical antimicrobial or as skin protectant in these products in an NDA, nor are these products lawfully marketed under the OTC Drug Review. In fact, neither benzethonium chloride nor benzalkonium chloride are included as active ingredients in the skin protectant TFM, and in the OTC antiseptic handwashes TFM, FDA classified both benzethonium chloride and benzalkonium chloride as "Category III" active ingredients because the safety and efficacy data available at that time were inconclusive to establish these ingredients as generally recognized as safe and effective when included in properly-formulated finished OTC drug products. TFM OTC Healthcare Antiseptic Drug Products, 59 Fed. Reg. at 31423; 31426. The false and misleading nature of this conflicting information causes these products to be misbranded under Section 502(a) of the Act. 21 U.S.C. § 352(a).

Third, the statements on the Fresh Protect Product labeling related to "time kill" in vitro testing refer to effectiveness testing conducted by [(b)(4)] in 2007. This testing was conducted on lots manufactured pursuant to a March 8, 2007, formulation of the Fresh Protect Products. The master formulation went through two significant reformulations in 2007; however, the later of which lot was used for commercial batches. Accordingly, the effectiveness statements are misleading in that they do not correspond to the product actually packaged.

Fourth, the Fresh Protect Products labels do not comply with the "Drug Facts" labeling requirements in 21 C.F.R. § 201.66. Therefore, they are misbranded and are being distributed by your firm in violation of Section 502(c) of the Act. 21 U.S.C. § 352(c).

B. The [(b)(4)] Products are Unapproved New Drugs and Are Misbranded

The recent FDA inspection disclosed the manufacturing, labeling, and distribution of [(b)(4)] Anti-Bacterial moisturizing lotion" by your firm. Based on the package labeling, this product is formulated with "Benzethonium Chloride, 0.2%" as the sole "Active Ingredient" and, like the Fresh Protect Products, it is offered as a no-rinse/leave-on OTC topical antimicrobial ("Place a small amount [(b)(4)] Moisturizing Lotion on the skin and rub until dry") with claims for extended efficacy ("Long Lasting Protection"). Thus, for the reasons described above with respect to the Fresh Protect Products, your "[(b)(4)] Anti-Bacterial moisturizing lotion" product is a "drug," and a "new drug" as defined by sections 201(g)(1) and 201(p) of the Act, respectively. 21 U.S.C. §§ 321(g)(1) and 321(p). It is intended to cure, mitigate, treat, or prevent disease caused by "illness and infection," there is no evidence that the product is considered GRASE by scientific experts, it does not comply with any OTC Monograph, and there is no evidence that the product falls within the pre-1972 marketing exception to the OTC drug review. It therefore is a new drug being distributed by your firm in violation of Sections 301(d) and 505(a) of the Act. 21 U.S.C. §§ 331(d) and 355(a).

The recent FDA inspection also disclosed information and labeling for an additional antibacterial lotion product manufactured by your firm. On the face of the labeling, the product contains the trade name of and active ingredient (i.e. [(b)(4)]) in an FDA-approved prescription drug product marketed by another firm for a different use. Displayed much less prominently, however, the package also contains the name "[(b)(4)] Anti-Bacterial moisturizing lotion," and states that it contains "Benzethonium Chloride 0.2%" as the "Active Ingredient." For the reasons set forth in the preceding paragraph with regard to the "[(b)(4)] product, this product is a "drug," as defined by Section 201(g)(1) of the Act (21 U.S.C. § 321(g)(1)), because it is intended to cure, mitigate, treat, or prevent disease. The distribution of this product by your firm in the United States in the absence of an approved application would violate Sections 301(d) and 505(a) of the Act. 21 U.S.C. §§ 331(d) and 355(a).

In addition, this anti-bacterial moisturizing lotion is misbranded. First, the label contains the names of two different active ingredients, [(b)(4)] and benzethonium chloride, when the product only contains one of those active ingredients. Next, the only name of a manufacturer listed is [(b)(4)] is the manufacturer of [(b)(4)] but is not the manufacturer of the anti-bacterial lotion, which is manufactured by your firm, Further, this label for your anti-bacterial moisturizing lotion contains information about the prescription drug, [(b)(4)] a product marketed under an FDA-approved NDA by [(b)(4)] that is intended for injection to stimulate bone marrow to produce white blood cells to help the body fight infection so as to facilitate chemotherapy. Because there are two product names with two different indications on the label, either your anti-bacterial lotion is purporting to be indicated for stimulating bone marrow to produce white blood cells or you are suggesting that your product is for use with the [(b)(4)] product. Either way, naming the two products together in the label is confusing and misleading. The statement "This bottle does not contain [(b)(4)]" which appears in small print on the side of the package labeling, does not mitigate the confusion. Thus, this antibacterial lotion is misbranded under Section 502(a) of the Act. 21 U.S.C. § 352(a).

This product also is misbranded because the labeling lacks directions and warnings, and fails to specifically disclose the name and location of the manufacturer of this OTC antibacterial lotion in violation of Sections 502(f)(1), (f)(2), and (b) of the Act, respectively. 21 U.S.C. §§ 352(f)(1), (f)(2) and (b).

Finally, both the [(b)(4)] Anti-Bacterial moisturizing lotion and the antibacterial lotion distributed under the name [(b)(4)] do not comply with the "Drug Facts" labeling requirements in 21 C.F.R. § 201.66. Therefore, they are misbranded in violation of Section 502(c) of the Act. 21 U.S.C. § 352(c).

C. The Stop, Motion, and Promise Products are Unapproved New Drugs and Misbranded

1. Factual Basis for Charges Relating to Stop, Motion, and Promise

The FDA inspection disclosed the marketing of three products intended and labeled for topical application to the lips. The "Stop" product indicates on its packaging label that it "Helps Stop Smoking," and is described as "A special botanical blend designed to calm and satisfy smokers who want to quit." The label also indicates, among other things, that the product is a "Lip Treatment" that is "Effective with Smokeless Tobacco." The directions for use state "Use often throughout the day & when the urge to smoke strikes." The "Motion" package label provides, among other things, that the product "Helps Relieve Motion Sickness" and is "Effective with All Types of Travel." The label directs application "When feeling queezy [sic] and motion sickness strikes, apply liberally to your lips! Reapply often. Best results when applied before & during traveling." "Promise" lip product package label indicates that it is a°Special botanical blend designed to help control appetite and maintain desired weight." The label states that the product "Helps Curb Appetite" and is "Effective Weight Management," and directs "Use often throughout the day & when the urge to snack or have a large meal strikes . . . Apply liberally to your lips!"

2. Stop, Motion, and Promise are Unapproved New Drugs

Based on the descriptions of these products from the package labeling described above, they are "drugs" as defined by Section 201(g)(1) of the Act (21 U.S.C. § 321(g)(1)), because they are intended to cure, mitigate, treat, or prevent disease or to affect the body's structures or functions.

These products also are "new drugs," as defined by Section 201(p) of the Act (21 U.S.C. § 32l(p)), because we are not aware of sufficient evidence to show that they are GRASE. Section 310.544 of part 21 of the C.F.R. specifically requires approval of a new drug application for OTC smoking deterrent drug products like "Stop," and no such application has been approved. The formulation and method of application for "Motion" do not satisfy the final monograph for OTC anti-emetic drug products, and with regard to "Promise," neither its formulation nor its labeling are covered by FDA's OTC Drug Review. There are no approved applications for Motion or Promise.

Because they are unapproved new drugs as detailed above, the marketing of these OTC drug products in the United States violates Sections 301(d) and 505(a) of the Act. 21 U.S.C. §§ 331(d) and 355(a)

3. Stop, Motion, and Promise are Misbranded

Stop is misbranded under 21 C.F.R. § 310.544 because it is a smoking cessation product that has not been approved under an NDA. 21 C.F.R. § 310.544 ("In the absence of an approved new drug application. . . such product is also misbranded under section 502 of the act."). In addition, Stop, Motion, and Promise do not comply with the "Drug Facts" labeling requirements in 21 C.F.R. § 201.66. Therefore, they are all misbranded and are being distributed by your firm in violation of Section 502(c) of the Act. 21 U.S.C. § 352(c).

D. Fresh Protect Sanitizing Bedsore Pre-Treatment Lotion and Fresh Protect Natural Antibacterial Hand Foam are Drugs and New Drugs Requiring FDA Approval

As recently as March 31, 2008, the Fresh Protect website (www.freshprotect.com) identified "Fresh Protect Sanitizing Bedsore Pre-Treatment Lotion" as a possible "FUTURE" product, formulated with "arnica and capsicum," for use as an antimicrobial lotion in preventing bedsores. At that time this web site also identified "Fresh Protect Natural Antibacterial Hand Foam" as currently available for purchase from your firm and claiming that it contains, among other ingredients, "Grapefruit Seed Extract" for use as "a natural antibacterial, antimicrobial, and antiviral disinfectant." Such claims would cause these products to be "drugs" as defined by section 201(g)(1) of the Act (21 U.S.C. § 321 (g)(1)). In addition, such products would also be "new drugs," as defined by section 201(p) of the Act (21 U.S.C. § 321(p)), because we are not aware of sufficient evidence to show that they are generally recognized as safe and effective for these uses. Neither the formulations nor the labeling described on your web site for these products is being considered under FDA's OTC Drug Review. Thus, absent an approved new drug application, marketing these OTC drug products in the United States would violate sections 301(d) and 505(a) of the Act (21 U.S.C. §§ 331(d) and 355(a)).

II. The Fresh Protect Products Are Adulterated Due to CGMP Violations at Your Manufacturing Facility

The CGMP deviations observed during the inspection demonstrate your firm's failure to comply with 21 C.F.R. Parts 210 and 211. As noted above, these deviations cause the Fresh Protect Products to"be adulterated within the meaning of Section 501(a)(2)(B) of the Act. 21 U.S.C. § 351(a)(2)(B). These deviations include, but are not limited to, the following:

A. Failure to perform for each batch of drug product appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release, as required by 21 C.F.R. § 211.165(a).

There is no finished product testing to determine the identity and strength of the active ingredient of the Fresh Protect Products prior to distribution. Mr. Mouser conceded this at the conclusion of the inspection. You therefore have no means of assuring that your finished products have the identity and strength they purport to have.

B. Failure to have written procedures defining the quality control unit's (QCU) responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products, and the QCU's authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated; and failure to have written QCU responsibilities for approving or rejecting all procedures or specifications impacting on the identity, strength, quality, and purity of the drug product, as required by 21 C.F.R. § 211.22.

Our inspection found that your firm does not have written procedures outlining the responsibilities and procedures applicable to the QCU.

We acknowledge that prior to the completion of the inspection you began to develop some quality control-type documents and that you provided our investigator with a draft document entitled "Quality Policy for the Quality System" that included a job description for the Quality Supervisor and for the President of Manufacturing. The Quality Supervisor job description specified that one of this individual's responsibilities is to assist in production operations including batch preparation and batch processing. The job description for the President of Manufacturing specified that some of this individual's responsibilities include overseeing the quality department and auditing manufacturing and quality processes. Please note that the quality control unit's function and responsibilities may not be subordinate to any other unit, including the production unit.

C. Failure to have written procedures for production and process controls designed to assure that drug products have the identity, strength, quality, and purity that they purport or are represented to possess, as required by 21 C.F.R. § 211.100(a). For example:

1. There are no written procedures setting forth nor has your firm conducted process validation studies for the Fresh Protect Products to demonstrate that the current ingredients, formula, and manufacturing process consistently produce a product that meets final specifications. Mr. Mouser conceded this at the conclusion of the inspection. Process validation is fundamental component of CGMP, the absence of which calls into question the identity, strength, quality, and purity of all drug product produced under such circumstances.

2. Your firm does not have change control procedures describing the mechanism for changing a process or procedure and for evaluating the effects and impact of manufacturing changes. The Master Batch record for Fresh Protect Sanitizing Hand Lotion had at least four substantial changes over the course of 2007, including changes to product formulation (e.g. [(b)(4)]) and changes in manufacturing methods (e.g. [(b)(4)]). These changes did not occur pursuant to an established change control procedure. They were made without justification or scientific rationale regarding why the changes were implemented, and without evaluation of the effects of these changes on the identity, strength, quality, and purity of the drug product.

D. Failure to have master production and control records that include complete manufacturing and control instructions, sampling and testing procedures, specifications, special notations, and precautions to be followed to assure drug product uniformity from batch to batch, as required by 21 C.F.R. § 211.186(b)(9).

For example, the master production and control record forms for the Fresh Protect Products do not specify the name of the active ingredient or its strength in the finished drug product, product specifications, or manufacturing instructions.

E. Failure to prepare batch production and control records for each batch of drug product produced with complete information relating to the production and control of each batch, as required by 21 C.F.R. § 211.188.

For example, a batch record was not prepared for Lot 23407 of Fresh Protect Sanitizing Hand Foam. In addition, when batch records were executed, the following information was not always documented: lot number of the components or in-process materials used in the process (e.g., see records for batches 34006, 34006, 28406, 26806, 26106, 31907, 30207, 11307, 06707, 00908); in-process laboratory testing results; and identification of all individuals performing significant steps of the manufacturing process and/or quality assurance (see records for batches 34006, 34006, 28406, 26806, 26106, 31907, 30207, 11307, 06707, 00908).

F. Failure to thoroughly investigate unexplained discrepancies or the failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed, as required by 21 C.F.R. § 211.192.

For example, three of [(b)(4)] batches of Fresh Protect Sanitizing Hand Lotion failed to meet the specification for pH (batches 06707, 11307, 23407) and four of [(b)(4)] batches failed to meet the temperature specification prior to filling (batches 34006, 34006, 11307, 23407). These discrepancies were not investigated by your firm and the batches were released for distribution.

The issues and violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your facility. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to assure 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. 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 considering the award of contracts. Additionally, FDA may withhold approval of requests for export certificates, or approval of pending new drug applications listing your facility as a manufacturer until the above violations are corrected. A reinspection may be necessary.

Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct violations. Include an explanation of each step being taken to completely correct the current violations and prevent the recurrence of violations, as well as copies of related documentation including any labeling you may have revised. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the corrections. If you no longer manufacture or market any of your products, or have destroyed or removed any of your products from the market as a result of the inspection, your response should so indicate, including the reasons for, and the dates on which these steps were performed.

Your response should be sent to the Food and Drug Administration, Seattle District Office, 22201 23rd Drive SE, Bothell, Washington, 98021-4421, to the attention of Lisa M. Althar, Compliance Officer. Should you have any questions concerning this letter, you can contact Ms. Althar at (425) 483-4940.

Sincerely,

/S/

Charles M. Breen
District Director

________________________________________________________

1. Since the inception of the OTC Drug Review, FDA has maintained that an OTC drug product is covered by that review as long as its formulation, dosage form, method of administration, and labeling existed in the OTC drug marketplace in the United States on or before May 11, 1972. See Procedures for Classification of OTC Drugs, 37 Fed. Reg. 9464 (May 11, 1972).