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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Concept Laboratories, Inc. 01-Sep-08

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

Public Health Service
Food and Drug Administration

 

Chicago District
550 West Jackson Blvd., 15th Floor
Chicago, Illinois 60661
Telephone: 312-353-5863



August 27, 2008


WARNING LETTER
CHI-5-08

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Joel Heifitz, Chief Executive Officer
Concept Laboratories, Inc.
1400 West Wabansia Avenue
Chicago, IL 60602

Dear Mr. Heifitz:

An inspection of Concept Laboratories, Inc., 1400 West Wabansia Avenue, Chicago, IL 60602, was conducted by a Food and Drug Administration (FDA) investigator from December 12, 2007 through January 18, 2008. The inspection revealed significant deviations from the current Good Manufacturing Practice (cGMP) regulations for Finished Pharmaceuticals, Title 21, Code of Federal Regulations (CFR), Parts 210 and 211, with regard to the production of pharmaceutical products by this facility. The deviations reported by the investigator caused your finished drugs to be adulterated within the meaning of 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 351(a)(2)(B)]. In addition, your firm also manufactures unapproved new drugs and misbranded drugs in violation of the Act under sections 502(a) [21 U.S.C. 352(a)], 502(c) [21 U.S.C. 352(c)], 502(e) [21 U.S.C. 352(e)], and 505(a) [21 U.S.C. 355(a)].

CGMP Deviations:

The following are examples of some of the significant cGMP deviations that were found during our inspection of your firm:

1. Failure of the Quality Control Unit (QCU) to investigate or maintain a written record of the investigation to include conclusions and follow-up of any unexplained discrepancy 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, and the failure to extend the investigation to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy, as required by 21 CFR 211.192.

For example, review of your firm's Drug Stability Long Term Report for the Skin Lightening Creme/Lotion revealed that the testing data for the three lots placed on stability for this product had [redacted] out-of-specification (OOS) results for [redacted] OOS results for pH; [redacted] OOS results for [redacted] and [redacted] OOS results for [redacted]. Investigations were not performed for any of these failures although your firm's SOP SP-016, "Deviation Procedure," states in Section 4.0 that the QCU shall conduct an investigation when a product fails to meet the established specifications.

For example, review of the Drug Stability Long Term Report for Pain Relief Creme revealed that for the three batches of this product which were placed on stability, there was [redacted] OOS result for [redacted] OOS results for [redacted] OOS results for [redacted] and [redacted] OOS result for [redacted] Investigations were not performed for any of these failures.

Your firm's response indicated that the FDA investigator's findings of OOS results were correct. However, it did not include any explanation or proposed corrective actions regarding the failure to conduct an investigation when these products are found out of the established specifications. In addition, the response stated that in the absence of process validation information for all of your drug products your firm relied on "long term stability results as criteria for release." Please note that the purpose of long term stability studies is to assess the stability characteristics of drug products to determine appropriate storage conditions and expiration dates. These studies can not be used to establish specifications for the drug product at the time of release for distribution.

The response also stated that your firm intends to develop a plan to implement process validation for all your drug formulations to accurately establish finished product release specifications. Based on the statements in your response, you appear to misunderstand the purpose of process validation studies. The product manufacturing process should be designed (based on thorough understanding of the impact of process variables on product attributes) to meet certain criteria (specifications) based on the intended use of the product. Once a commercial manufacturing process is finalized, a validation study (or studies) is conducted to demonstrate that the manufacturing process as designed consistently produces product that meets the predetermined specifications. The process validation studies are not used to establish the finished product release specifications.

Finally, the response did not include any interim procedure to be implemented prior to the completion of the process validation studies.

2. Failure to establish written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess as required by 21 CFR 211.100(a).

For example, process validation studies have not been conducted for any of the human drug products manufactured by your firm.

Your firm's response included copies of a draft Master Validation Plan and draft Process Validation Forms that will be used in the execution of a process validation study and a draft of the Process Validation Protocol for Capsaicin Gels as an example. The response does not provide a timeline, plan, or estimated completion date for the process validation studies.

3. Failure to follow written production and process control procedures as required by 21 CFR 211.100(b).

Deviations from written production and process control procedures were not justified.

For example, the batch record for EMU Essentials Pain Relieving Cream, lot 19462, documented that step AB was mixed for [redacted] rather than the required mixing time of [redacted] Step C was mixed for [redacted] rather than the required mixing time of [redacted] Step D-1 was mixed for [redacted] rather than the required mixing time of [redacted] and Step E was mixed for [redacted] rather than the required mixing time of [redacted].

The batch record for the Anti-Aging Skin Lightening Cream (Miracle Fade Creme Skin Lightening), Lot 01663, documented that Step C-2 was mixed for [redacted] rather than the required mixing time [redacted]. Also, Step D-3, which includes the addition of the active ingredient Hydroquinone, was mixed for [redacted] rather than the required mixing time of [redacted]

Your firm's response indicated that compounding personnel were counseled on the mixing time discrepancies. However, no details were provided about the content of the training (e.g., the cGMP requirement to follow established procedures). In addition, your firm committed to review each batch record for conformance to the mixing time requirements and that justified deviations from established procedures will be investigated to assess how the deviation will affect the release criteria of the drug product. However, the procedures describing when the record will be reviewed (e .g., prior to executing the next processing step) or the particular steps to follow when conducting an investigation of these types of discrepancies were not provided.

This observation is of particular concern in light of the findings of drug products that failed to meet the established specifications and were released (item 1 above) and your firm's failure to complete process validation studies for any of the drug products manufactured at the site (item 2 above).

4. Failure to adequately clean, maintain, and sanitize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality or purity of the drug product and failure to follow written procedures for cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing, or holding of a drug product as required by 21 CFR 211.67(a) & (b).

For example, your firm failed to have cleaning validation studies for all the products you manufacture with the shared manufacturing equipment used to manufacture drug products and household cleaning agents and other industrial products. Also, the Cleaning Validation Master Protocol does not include a scientific rationale for the products selected, sampling sites, equipment used, and acceptance criteria established. In addition, your firm's cleaning and sanitization records do not document whether the required contact times (times detergents and solvents are in contact with the equipment surface) described in the procedure are met or document the preparation of either the cleaning agent [redacted] or the sanitizing agent, Sodium Hypochlorite, 12.5%, used during cleaning.

Your firm's response indicated that two cleaning validation studies had been completed and your commitment to complete cleaning validation for all other drug products. The response also stated that a high performance liquid chromatography (HPLC) instrument was purchased. You also stated that you intend to perform some of the analytical testing currently performed by a contract laboratory and that you are in the process of hiring an analytical chemist to perform testing and participate in the cleaning validation studies. The response, however, did not include documentation of the cleaning validation studies already completed for our evaluation. It also failed to specify for which two drug products the studies were completed. In addition, the response did not include a timeline for completion of the remaining cleaning validation studies.

Your firm's response also mentioned you are planning to buy additional manufacturing equipment and states your commitment to dedicate this equipment to the manufacture of household and cleaning products. However, interim corrective actions were not proposed for those drug products manufactured after the manufacture of household cleaning and industrial products, particularly in light of your failure to complete cleaning validation studies.

Please note that deficiencies with cleaning validation were documented in the inspections conducted on September 29, 2004, and September 30, 2005. In a letter dated December 12, 2005, you indicated that cleaning validation studies would be completed by approximately December 2006.

5. Failure to have laboratory records that include complete data derived from all tests necessary to assure compliance with established specifications and standards, including examinations and assays such as a statement of the results of tests and how the results compare with established standards of identity, strength, quality, and purity for the component, drug product container, closure, in-process material, or drug product tested as required by 21 CFR 211.194(a)(6).

Your laboratory records did not include complete data necessary to assure compliance with established specifications and standards, because in certain instances the laboratory records used different specifications for evaluating the compliance of test results for the same lot. For example, review of the complaint investigation (CC06-004) for an adverse reaction for Anti-Aging Skin Lightening Creme/Lotion, lot 01663, documented that the laboratory report (Line Sample Analysis of Drug Finished Product Form") of the retesting completed as part of the investigation included a viscosity specification of [redacted]-[redacted] cps which conforms to the established specification. However, the laboratory report of testing as part of routine lot testing of this lot included a different viscosity specification of [redacted]-[redacted] cps.

In addition, review of the laboratory reports for Pain Relief Creme, lot 19462, documented that reports associated with testing of the same lot filled on different days included different specifications for specific gravity.

Please note that specifications must be consistent and controlled to assure that they are accurately transferred to other applicable documents in order to ensure that re-testing results, for example, are compared to the proper specifications. Your firm's response indicated that the laboratory procedure for the control of specifications for drug products will be updated to include specifications as part of the master batch record. The current practice involves printing uncontrolled individual Line Sample Analysis of Drug Finished Product Forms from a computer. It is unclear to us how the proposed corrective action will address the issue. In addition, the response did not include a copy of the revised procedure.

Unapproved and Misbranded Drugs

A. Miracle Fade Creme Skin Lightening (4oz) and Licorice Root Skin Lightening Lotion (8.5oz)

Based on review of the label for the Miracle Fade Creme Skin Lightening (4oz) and Licorice Root Skin Lightening Lotion (8.5oz), your products are drugs as defined in section 201(g) of the Act [21 U.S.C. §321(g)] . Because these products are intended for skin lightening, they are a skin bleaching product and are subject to the Skin Bleaching developing monograph (21 CFR part 358 subpart A): Miscellaneous External Drug Products for Over-the-Counter for Human Use: Skin Bleaching Drug Products.

Pursuant to FDA's Over-the-Counter (OTC) Drug Review, FDA published a tentative final monograph (TFM) for OTC skin bleaching drug products, in the Federal Register (Fed. Reg.) of November 21, 1978 (43 FR 51546). This TFM is available on FDA's Internet Web site at: http://www.fda.gov/cder/otcmonographs/category_sort/skin_bleaching.htm. Pending a final monograph/rule, the agency does not object to the marketing of products that meet both the formulation and labeling requirements described in this TFM.

All OTC drug products marketed in the United States, including OTC skin bleaching products, are subject to drag establishment registration, drug listing, and current good manufacturing practice (cGMP) regulations, as well as all existing drug labeling requirements described in section 502 of the Act [21 U.S.C. 352] and in Title 21 of the Code of Federal Regulations, Part 201 (21 CFR 201), including the "Drug Facts" labeling requirements under 21 CFR 201.66.

We note your products Miracle Fade Creme Skin Lightening and Licorice Root Skin Lightening Lotion are similarly packaged as a container inside a clear plastic bag along with a folded insert. The label of the outer immediate container does not list inactive ingredients and the inactive ingredients listed on the insert labeling are not easily legible through the plastic bags containing your products. Therefore, your products are misbranded under section 502(e)(1)(A)(iii) of the Act [21 U.S.C. 352(e)(1)(A)(iii)] in that the established name of each inactive ingredient is not listed on the outer containers as required by 21 CFR 201.66(c)(8).

In addition, your products are misbranded under section 502(c) of the Act [21 U.S.C. 352(c)] in that such required information, "Inactive Ingredients," is not placed with such conspicuousness and in such terms as to render them likely to be read and understood by the ordinary individual at the time of purchase and use.

B. EMU Essentials Pain Relieving Formula (9 oz and 2 oz), EMU Essentials Pain Relieving Roll-On 3 oz, Glucosamine Blue Pain Relieving Cream (9 oz )

The labeling for EMU Essentials Pain Relieving Formula in both 9 oz and 2 oz, EMU Essentials Pain Relieving Roll-On 3 oz, and Glucosamine Blue Pain Relieving Cream 9 oz. promote the products for conditions that cause them to be drugs under section 201(g)(1) of the Act [21 U.S.C. 321(g)(1)]. The labeling for EMU Essentials Pain Relieving Formula in both 9 oz and 2 oz, EMU Essentials Pain Relieving Roll-On 3 oz, and Glucosamine Blue Pain Relieving Cream 9 oz. include therapeutic claims such as, "for the temporary relief of minor aches and pains of muscles and joint associated with a [] simple backache [] arthritis [] strains [] sprains . . .." that establish that these products are drugs, because they are intended for use in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man. The products, their formulations and their corresponding misbranding violations are described below:

EMU Essentials Pain Relieving Formula (9 oz. 2 oz) and EMU Essentials Pain Relieving Roll-On (3 oz):

Based on the product labels, the formulas for both EMU Essentials products are the same. The active ingredient is Capsicum Oleoresin 0.0625% (containing Capsaicin 0.025%). The inactive ingredients are Water (Aqua), Glyceryl Stearate SE, Glycerin, Ceteareth-20, Cetearyl Alcohol, Mineral Oil, Isopropyl Myristate, Petrolatum, Emu Oil, PEG-75 Lanolin, Dimethyl Sulfone, Glucosamine HCl, PEG-40 Hydrogenated Castor Oil, Aloe Barbadensis Leaf Juice, DMDM Hydantoin, Methylparaben, Propylparaben, Fragrance, Blue 1.

Glucosamine Blue Pain Relieving Cream (9 oz):

Based on the product label, the active ingredient for Glucosamine Blue Pain Relieving Cream is Capsicum Oleoresin 0.0625% (containing Capsaicin 0.025%). The inactive ingredients are Water (Aqua), Glyceryl Stearate SE, Ceteareth-20, Glycerin, Cetearyl Alcohol, Mineral Oil, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Petrolatum, Linum Usitatissimum (Linseed) Seed Oil, Emu Oil, PEG-75 Lanolin, Dimethyl Sulfone, Glucosamine HCl, PEG-40 Hydrogenated Castor Oil, Propylene Glycol, DMDM Hydantoin, Methylparaben, Propylparaben, Fragrance, Blue 1.

With regard to the labeling and formulation for EMU Essentials Pain Relieving Formula in both 9 oz and 2 oz, EMU Essentials Pain Relieving Roll-On 3 oz, and Glucosamine Blue Pain Relieving Cream 9 oz, we object to the promotion of listed inactive ingredients on the principal display panel of the products' labels. EMU Essentials Pain Relieving Formula, 9 oz and 2 oz, and EMU Essentials Pain Relieving Roll-On 3 oz, feature the EMU oil ingredient on the principal display panel because of the name of the product, i.e., "EMU" Essentials. This suggests that the Emu oil is the most important ingredient in the product, and an active ingredient as defined in 21 CFR 201.66(b)(2) because it is intended to furnish effect in treating, preventing, or mitigating disease or affecting the structure or function of the body. The Glucosamine Blue Pain Relieving Cream, in using the Glucosamine ingredient in its name, also prominently features the Glucosamine ingredient on the principal display panel as if it were an active ingredient and the most important ingredient in the product. When an ingredient is prominently featured on the principal display panel of the product, it is misleading in that it represents and suggests a therapeutic significance for that ingredient see 21 CFR 201.10(c)(4)). This misleading labeling misbrands EMU Essentials Pain Relieving Formula in both 9 oz and 2 oz, EMU Essentials Pain Relieving Roll-On 3 oz, and Glucosamine Blue Pain Relieving Cream 9 oz. under Section 502(a) of the Act, [21 U.S.C. 352(a)].

In addition, the products EMU Essentials Pain Relieving Formula 2 oz and EMU Essentials Pain Relieving Roll-On 3 oz are further misbranded under section 502(c) of the Act [21 U.S.C 352(c)] because all of the labeling required under the format and content requirements discussed in 21 CFR 201.66 are not conspicuous at the time of purchase. For example, under the heading "Other Information'° on the drug facts panel of these drag products, it states, "Read and Understand enclosed Pamphlet, Directions and Warnings before using." This statement is unacceptable, because required information, such as directions and warnings, must be included (i.e., conspicuous at the time of purchase) in the drug facts panel pursuant to 21 CFR 201.66, and not simply in accompanying labeling.

C. The SkinZinc System and SkinZium System

The labeling for the "SkinZinc System" and "SkinZium System" promote the products for conditions that cause them to be drugs under section 201(g) of the Act [21 U.S.C. 321(g)(1)]. Because the "SkinZinc System" is intended for the treatment of psoriasis, seborrhea dermatitis, and dandruff, it is subject to the OTC final rule for control of dandruff, seborrheic dermatitis, or psoriasis (21 CFR Part 358, Subpart H). In addition, because the "SkinZium System" is intended for the treatment of eczema, rashes, and minor skin irritations, as well as the temporary protection of minor cuts, scrapes, burns and chapped or cracked skin, it is subject to the OTC final rule for skin protectant drug products for OTC human use (21 CFR Part 347, Subpart B and Subpart Q.

The "SkinZinc System" consisting of "SkinZinc Spray" 4oz and "SkinCylic Cream" 4oz is a product that consists of both the "SkinZinc Spray" 4oz (Seborrhea Dermatitis Spray with Zinc Pyrithione 0.25%) and "SkinCylic Cream" 4oz (Psoriasis Cream with Salicylic Acid 2%). Labeling and promotional material that accompanies these products states that the "SkinZinc System" is a "multi-symptom two-phase relief system" that is useful in treating psoriasis, seborrhea dermatitis and dandruff. The labeling describes "SkinZinc Spray" as "Phase 1" and "SkinCylic Cream" as "Phase 2". As described in more detail below, the labeling and promotion for these products includes statements and representations inconsistent with labeling allowed under FDA's OTC Drug Review and violates provisions of the Act.

The following statements from labeling and promotional material for the "SkinZinc System" demonstrate the intended uses of the product:

"Multi-Symptom, Two-Phase Relief System *Includes SkinCylic Cream for the relief of the symptoms of PSORIASIS *Also includes SkinZinc Spray for the relief of the symptoms of SEBORRHEIC DERMATITIS & DANDRUFF"

"The SkinZinc System is used to eliminate even stubborn symptoms associated with psoriasis, seborrhea dermatitis and dandruff."

"The SkinZinc System delivers Broad Spectrum Relief from the most troublesome symptoms associated with Psoriasis, Seborrheic Dermatitis and Dandruff"

The following statements on the labeling for the "SkinZinc System" demonstrate that "SkinZinc Spray" and "SkinCylic Cream" are to be used in conjunction with each other as a "TWO-PHASE RELIEF SYSTEM' to treat the conditions described above:

"Two-Phase Relief System"

"Phase 1-Medicated SkinZinc Spray - Refreshing mist spray goes on like water to stop and relieve. Phase 2-Medicated SkinCylic Cream Feathery-light, fragrance free, fast absorbing to eliminate and control."

"Do not apply SkinZinc Spray immediately over SkinCylic Cream. Wait 1 to 2 hours."

"Do not apply SkinCylic Cream immediately over SkinZinc Spray. Wait 1 to 2 hours."

The following statements on the immediate label for the "SkinZinc Spray" and "SkinCylic Cream" further demonstrate that "SkinZinc Spray" and "SkinCylic Cream" are to be used in conjunction with each other to treat the conditions described above.

"Phase 1 SkinZinc System""Do not apply SkinZinc Spray immediately over SkinCylic Cream. Wait 1 to 2 hours." Labeling for "SkinZinc Spray"

'"Phase 2 SkinZinc System"
"Do not apply. SkinCylic Cream immediately over SkinZinc Spray. Wait 1 to 2 hours." Labeling for "SkinCylic Cream "

The "SkinZinc System" as a "TWO-PHASE RELIEF SYSTEM" is not generally recognized as a safe and effective treatment for psoriasis. The only active ingredient in the "SkinZinc System" that is permitted for use in treating psoriasis under the OTC final rule for control of dandruff, seborrheic dermatitis, or psoriasis, is salicylic acid [21 CFR Part 358, Subpart H, Section 358.710(c)(2)]. The other active ingredient, zinc pyrithione, is not permitted for that use under the OTC final rule [21 CFR Part 358, Subpart H, Section 358.710(c)]. Therefore, the "SkinZinc System" consisting of "SkinZinc Spray" and "SkinCylic Cream" is a "new drug" as defined by Section 201(p) of the Act [21 U.S.C. 321(p)]. Because the SkinZinc System is not the subject of an approved new drug application, its marketing in the United States violates Section 505(a) of the Act [21 U.S.C. 355].

"SkinZium System" consisting of: "SkinZinc Spray" 2oz and "SkinZium Cream" 4 oz

The "SkinZium System" is a product that consists of both the "SkinZinc Spray" 2 oz (Seborrheic Dermatitis Spray with Zinc Pyrithione 0.25%) and "SkinZium Cream" 4 oz (Eczema Cream with Mineral Oil 32%, Colloidal Oatmeal 3%, and Allantoin 0.6%). Labeling and promotional material that accompanies these products states that the "SkinZium System" is a "Two-Phase Relief System" ("SkinZinc Spray" as "Phase 1" and "SkinZium Cream" as "Phase 2") that is useful in treating eczema, scrapes, burns, minor skin irritations, seborrheic dermatitis and dandruff.

The following statements on the labeling for the "SkinZium System" demonstrate that "SkinZinc Spray" and "SkinZium Cream" are to be used in conjunction with each other to treat eczema, scrapes, burns, rashes, chapped or cracked skin, minor skin irritations, seborrheic dermatitis, and dandruff

"Two-Phase Relief System"

"Phase 1-Intensive therapy cooling spray is light without steroids, without staining your clothes, and without a smelly mess."

"Phase 2-Intensive therapy protectant cream is light, fast-absorbing, and non-greasy for immediate and continuous relief."

"Intense Combination Therapy to Relieve, Eliminate, and Control"

"Will the SkinZium™ System work if I use just the spray or the cream? Yes, using either the spray or the cream will help eliminate itching, scaling, flaking, redness and irritation of the skin. However, using both the medicated spray and cream together as directed will deliver the powerful relief SkinZium® System is known for."

The "SkinZium System" as a "TWO-PHASE RELIEF SYSTEM" and as formulated is not in compliance with the regulations for the conditions listed above. As a treatment for eczema, rashes, and minor skin irritations, the "SkinZium System" must be formulated and labeled in accord with the OTC final rule for skin protectant drug products for OTC human use, 21 CFR Part 347, Subpart B and Subpart C. For instance, under 21 CFR 347.10; 21 CFR 347.20(a)(4) and 21 CFR 347.50(b)(7), mineral oil between 30 to 35 percent may be combined with colloidal oatmeal at a 0.003 percent minimum in order to be generally recognized as safe and effective and not misbranded when offered for the protection and relief of minor skin irritation and itching due to rashes and eczema. However, the combination of the active ingredients, miner al oil 32%, colloidal oatmeal 3%, and allantoin 0.6%, for the uses in "Phase 2" (SkinZium Cream) of the "SkinZium System" is not acceptable in that allantoin is not permitted, alone or in combination with colloidal oatmeal and mineral oil, for those uses under these regulations. In addition, the "Phase 1" (SkinZinc Spray) active ingredient, zinc pyrithione, is not acceptable under these regulations, alone or in combination with the "Phase 2" (SkinZium Cream) active ingredients, for use in treating minor skin irritations and itching due to rashes and eczema.

Similarly, as a treatment for the temporary protection of minor cuts, scrapes, burns and chapped or cracked skin, the "SkinZium System" must be formulated and labeled in accordance with the OTC final rule for skin protect ant drug products for OTC human use 21 CFR Part 347, Subpart B and Subpart C. For instance, under 21 CFR 347.10; 21 CFR 347 .20(a)(1) and (2) and 21 CFR 347.50(b)(1) and (2), allantoin between 0.5 and 2 percent may be combined with mineral oil between 50 to 100 percent in order to be generally recognized as safe and effective and not misbranded for the temporary protection of minor cuts, scrapes, bums and chapped or cracked skin. However, the combination of the active ingredients, mineral oil 32%, colloidal oatmeal 3%, and allantoin 0.6% in "Phase 2" (SkinZium Cream) of the "SkinZium System" is not acceptable for these uses under these regulations. Colloidal oatmeal is not acceptable, alone or in combination, with mineral oil and allantoin, for these uses under these regulations . Likewise, the "Phase 1" (SkinZinc Spray) active ingredient, zinc pyrithione, alone or in combination with the "Phase 2" active ingredients, is not acceptable for these uses under these regulations.

Further, as a treatment for seborrheic dermatitis and dandruff, the "SkinZium System" must be formulated and labeled in accord with the OTC final rule for the control of dandruff, seborrheic dermatitis, or psoriasis, 21 CFR Part 358, Subpart H. Under 21 CFR 358.710(a)(3) and (b)(3), the active ingredient, zinc pyrithione, in "Phase 1" (SkinZinc Spray) of the "SkinZium System" is acceptable for use in treating seborrheic dermatitis and dandruff. However, it is not acceptable for these uses under these regulations for zinc pyrithione in "Phase 1" to be used in conjunction with the combination of the active ingredients, mineral oil 32%, colloidal oatmeal 3%, and allantoin 0.6% in "Phase 2" (SkinZium Cream) of the "SkinZium System," as represented or suggested in the labeling of the "Two-Phase Relief System." These "Phase 2" ingredients are not acceptable, on their own or in combination with the zinc pyrithione ingredient, for the treatment of seborrheic dermatitis or d dandruff under these regulations.

Therefore, the "SkinZium System" consisting of "SkinZinc Spray" and "SkinZium Cream" is a "new drug" as defined by section 201(p) of the Act [21 U.S.C. 321(p)]. Because the "SkinZium System" is not the subject of an approved new drug application, its marketing in the United States violates section 505(a) of the Act (21 U.S.C. 355).

We acknowledge receipt of your firm's written response dated February 22, 2008, to the Form FDA 483 issued to you at the conclusion of the inspection. The issues and violations cited in this letter are not intended to be an all-inclusive list 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 conduct a comprehensive audit of your facility and operations and assure compliance with all requirements of the Act 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 regulatory action without further notice, including, without limitation, seizure and/or 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 new drug applications listing your facility as a manufacturer until the above violations are corrected. A reinspection may be necessary.

Within 15 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 prevent the recurrence of violations as well as copies of related documentation. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the correction. If you no longer manufacture or market any drug products, your response should so indicate, including the reasons for, and the date on which you ceased production.

Your response should be directed to the attention of Compliance Officer George F. Bailey at the address listed above. If you have any questions regarding any issue in this letter, please contact Mr. Bailey at (312) 353-5863.

Sincerely,

/S/

Scott J. Maclntire
Chicago District Director