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  1. Warning Letters

WARNING LETTER

ASA Universal Inc. d/b/a Sonage MARCS-CMS 564038 —


Delivery Method:
VIA SIGNATURE CONFIRMED DELIVE
Product:
Drugs

Recipient:
Recipient Name
Ms. Sujata Bahri
Recipient Title
Chief Operating Officer
ASA Universal Inc. d/b/a Sonage

23285 Ventura Boulevard
Woodland Hills, CA 91364
United States

Issuing Office:
Division of Pharmaceutical Quality Operations IV

United States


WARNING LETTER

November 27, 2018

Dear Ms. Bahri:

The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, ASA Universal Inc. d/b/a Sonage, FEI No. 3012114283, located at 23285 Ventura Boulevard, Woodland Hills, California, from June 12 to 19, 2018.

This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. See 21 CFR, parts 210 and 211.

Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).

As formulated and labeled, Sonage Opalex Lightening Serum and Sonage Laserine Botanical Salve are unapproved new drugs in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). Introduction of such products into interstate commerce is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. 331(d). Sonage Acne Control Therapy, Sonage Presage Moisturizer SPF 15, and Sonage Protect Plus Natural SPF 30 are misbranded under section 502(c) of the FD&C Act, 21 U.S.C. 352(c). Sonage Acne Control Therapy and Sonage Presage Moisturizer SPF 15 are misbranded under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1). Sonage Presage Moisturizer SPF 15 is also misbranded under sections 502(a) and (f)(2) of the FD&C Act, 21 U.S.C. 352(a) and (f)(2). Introduction of such products into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a). These violations are described in more detail below.

We reviewed your July 6, 2018, response in detail and acknowledge receipt of your subsequent correspondence.

During our inspection, our investigator observed specific violations including, but not limited to, the following.

1. Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products (21 CFR 211.22(a)).

Your firm lacks an adequate quality unit. You have not established written procedures that define the roles, responsibilities, and authorities of a quality unit. You also lack a written process for making batch disposition decisions. Furthermore, your quality unit failed to review documentation for numerous basic drug repackaging operations, including but not limited to procedures for production, complaint investigations, and cleaning equipment.

See FDA’s guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations for help with implementing modern quality systems and risk management approaches to meet the requirements of CGMP regulations (21 CFR, parts 210 and 211), at https://www.fda.gov/downloads/Drugs/Guidances/UCM070337.pdf.

In your response, you indicated that corrective actions were implemented to address these deficiencies. Your response is inadequate because you did not provide documentation of your corrective actions, including, but not limited to, documentation of your updated procedures (for example, procedures for document review, product release, complaint, batch production records, and cleaning), complaint investigation, and equipment cleaning validation.

In response to this letter, provide:

  • Your corrective action and preventive action (CAPA) plan to ensure that you establish an effective quality unit with appropriate authority and sufficient resources to carry out its responsibilities and consistently ensure drug quality. Your response should also include a detailed procedure describing your remediated quality unit’s responsibilities.
  • A copy of all updated procedures detailed in your response.
  • A complete investigation of the complaint for a “reaction” related to Sonage Sunscreen Natural Plus SPF30, Batch S1024BA.
  • Documentation of your cleaning validation for equipment used in drug product repackaging operations.

2. Your firm failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products (21 CFR 211.166(a)).

You have not established a stability program for your repackaged drug products, including written procedures. Your product is received in bulk containers and repackaged into smaller containers. Your over-the-counter (OTC) drug products do not have stability testing data to support the shelf life for Sonage Protec Plus Natural SPF 30, Sonage Presage Moisturizer SPF 15, and Sonage Acne Control Therapy drug products in their marketed container closures.

In your response, you acknowledge the lack of stability studies in the same container closure system in which drug products are repacked, sold, and shipped. Your response is inadequate because it does not include stability studies for your repackaged drug products.

In response to this letter, provide:

  • The stability testing protocol for your drug products. If the protocol has been executed or is in the process of being executed, provide an update and any test results.
  • A retroactive assessment of the stability of drug products currently on the U.S. market within expiry. Include your CAPA plan to ensure that these drug products will maintain their purported quality attributes through their expiry.
  • A comprehensive review and CAPA plan to ensure that your stability program supports initial distribution and ongoing stability of all your drug products.

Access to Information During the Inspection

During the inspection, our investigator made repeated requests for copies of certain documents, such as the specification sheet for your bottles and a product label. Despite having several days during the inspection to produce these documents, you did not do so. These documents were also not included with your response.

When an owner, operator, or agent delays, denies, limits, or refuses an inspection, the drugs manufactured, processed, packed, or held in the facility may be deemed adulterated under section 501(j) of the FD&C Act. See FDA’s guidance document Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection at https://www.fda.gov/downloads/regulatoryinformation/guidances/ucm360484.pdf.

CGMP Consultant Recommended

Based upon the nature of the violations we identified at your firm, we strongly recommend engaging a consultant, qualified as set forth in 21 CFR 211.34, to assist your firm in meeting CGMP requirements.

Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for fully resolving all deficiencies and for ensuring ongoing CGMP compliance.

Unapproved New Drug Charges

Sonage Laserine Botanical Salve

Sonage Laserine Botanical Salve is a “drug” as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body.

The Sonage Laserine Botanical Salve label provides your product’s website, www.sonage.com, which is considered labeling. Examples of claims observed on your product labeling for Sonage Laserine Botanical Salve that establish the intended uses of the product as defined in 21 CFR 201.128 include, but may not be limited to, the following:

Website Labeling Claims:

“…skin protectant … anti-irritant, anti-bacterial, anti-acne properties … therapeutic for various skin conditions such as eczema, psoriasis, seborrhea, fungal infections, and rosacea … anti-inflammatory … antiseptic…”

OTC drug products intended for use as skin protectants, antifungals, acne products and psoriasis/seborrhea products are subject to the following final rules: Skin Protectant Drug Products for Over-the-Counter Use Final Rule, see 21 CFR 347; Topical Antimicrobial Drug Products for Over-the-Counter Use Topical Antifungal Drug Products Final Rule, see 21 CFR 333 Subpart C; Topical Antimicrobial Drug Products for Over-the-Counter Use Topical Acne Drug Products Final Rule, see 21 CFR 333 Subpart D; and the Miscellaneous External Drug Products for Over-the-Counter Human Use Drug Products for the Control of Dandruff, Seborrheic Dermatitis, and Psoriasis Final Rule, see 21 CFR 358 Subpart H. However, this product is not labeled or formulated in accordance with these final rules for the reasons explained below.

Sonage Laserine Botanical Salve is a six-way combination product because the formulation and labeling is subject to six monograph rulemakings. The final rules listed above do not permit such a six-way combination product. Furthermore, the product labeling states that it is therapeutic for rosacea. Rosacea is not discussed in any rulemaking and is not being considered under the OTC Drug Review. Thus, as formulated and labeled, Sonage Laserine Botanical Salve does not comply with the rulemakings described above. Furthermore, we are not aware of sufficient evidence to show Sonage Laserine Botanical Salve, as formulated and labeled, is generally recognized as safe and effective. Therefore, this product is a new drug within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p). As a new drug, Sonage Laserine Botanical Salve may not be legally marketed in the United States absent approval of an application filed in accordance with section 505(a) of the FD&C Act, 21 U.S.C. 355(a). Sonage Laserine Botanical Salve is not the subject of an approved new drug application, and therefore, the current marketing of this product violates section 505(a) of the FD&C Act, 21 U.S.C. 355(a). Introduction of such products into interstate commerce is prohibited under 301(d) of the FD&C Act, 21 U.S.C. 331(d).

Sonage Opalex Lightening Serum

Sonage Opalex Lightening Serum is a “drug” as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body. Specifically, this product is intended as a skin bleaching drug product.

Examples of claims observed on your product label and on your labeling which includes your product website, www.sonage.com for Sonage Opalex Lightening Serum that establish the intended uses of the product as defined in 21 CFR 201.128 include, but may not be limited to, the following:

Label Claims:

“…Hydroquinone-free skin lightener…”

Website Labeling Claims:

“…Hydroquinone-free skin lightening serum with six natural actives—including arbutin—
targets hyperpigmentation and dark spots…Hydroquinone-free potent skin lightener…
Botanical blend inhibits pigmentation…”

Drug products intended for skin bleaching, such as Sonage Opalex Lightening Serum are being evaluated under the developing rule for Skin Bleaching Drug Products for OTC Human Use (47 FR 39108, September 3, 1982). Pending the promulgation of a Final Rule, the agency generally does not intend to object to the marketing of products that meet both the proposed formulation and labeling conditions outlined in the TFM and each general condition in 21 CFR 330.1 unless a particular product poses a public health concern. Such marketing, however, is subject to the risk that a Final Rule may require reformulation and/or relabeling or FDA approval through the “new drug” procedures of the FD&C Act (section 505).

The labeling and formulation for Sonage Opalex Lightening Serum is not consistent with the conditions proposed for skin bleaching drug products, see 47 FR 39108, September 3, 1982. Specifically, the label for Sonage Opalex Lightening Serum does not distinguish active ingredients from inactive ingredients. Therefore, all of the labeled ingredients (water, glycerin, alpha-arbutin, niacinamide (vitamin b3), kojic acid, azelaic acid, mandelic acid, glycyrrhizic acid (licorice) root extract, morus alba (mulberry) root extract, carbomer, acrylates/c1030 alkyl acrylate crosspolymer, xanthan gum, sodium hyaluronate, caprylic/capric triglyceride (coconut), citrus limon (lemon) peel extract, citrus aurantium dulcis (orange) fruit extract, citrus aurantiifolia (lime) peel extract, salvia officinalis (sage) leaf extract, pyrus malus (apple) fruit extract, vanilla planifolia fruit extract, cucumis sativus (cucumber) fruit extract, hydrolyzed oat protein, potassium cocoate) are deemed to be represented as active ingredients, see 21 CFR 201.66(b)(2). Such a product formulated and labeled as Sonage Opalex Lightening Serum, is not consistent with the conditions proposed in the above TFM.

Furthermore, we are not aware of any adequate and well controlled clinical trials in the published literature that support a determination that Sonage Opalex Lightening Serum is generally recognized as safe and effective for its labeled indications. Additionally, we are not aware of a similar OTC product as formulated and labeled that was available in the United States market on or before the inception of the OTC Drug Review.

Sonage Opalex Lightening Serum, as formulated and labeled, is therefore a new drug within the meaning of section 201(p) of the FD&C Act because it is not generally recognized among scientific experts as safe and effective for the drug uses described in its labeling. “New drugs” may not be introduced or delivered for introduction into interstate commerce unless an application approved by FDA under section 505 of the FD&C Act is in effect for the drug. Sonage Opalex Lightening Serum is not the subject of an approved new drug application; therefore, marketing this product in the United States is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. 331(d), and violates section 505 of the FD&C Act.

Misbranding Drug Charges

Sonage Acne Control Therapy

Sonage Acne Control Therapy is a “drug” as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is intended for the diagnosis, cure, mitigation, treatment, or prevention of disease; and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body. Specifically, this product is intended as an acne drug product.

Examples of claims observed on your product label and in your labeling (which includes your product website, www.sonage.com) for Sonage Acne Control Therapy that establish the intended uses of the product as defined in 21 CFR 201.128 include, but may not be limited to, the following:

Label Claims:

“…Prevents Blemishes...”

Website Labeling Claims:

“…Combats acne and breakouts…”

The labeling for such drugs, as with all OTC drugs, must comply with all the requirements of section 502 of the FD&C Act and all pertinent regulations found in Title 21 of the Code of Federal Regulations (21 CFR). However, your product does not meet these requirements for the reasons described below.

  • Sonage Acne Control Therapy is misbranded under section 502(c) of the FD&C Act, 21 U.S.C. 352(c), for multiple reasons. Specifically, the product is not labeled in accordance with the “Drug Facts” labeling requirements described in 21 CFR 201.66 because “Drug Facts” does not appear on the product label. Therefore, this product is misbranded under section 502(c) of the FD&C Act, 21 U.S.C. 352(c), because the information that is required to appear on the labeling is not prominently placed thereon with such conspicuousness and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
  • Sonage Acne Control Therapy is further misbranded within the meaning of section 502(c) of the FD&C Act, 21 U.S.C. 352(c), because the label fails to bear a statement of identity as required under 21 CFR 201.61. The label for this product fails to include the general pharmacological action(s) or principal intended action(s) of the product. Specifically, the label fails to identify the product as an “acne medication” and/or “acne treatment,” followed by dosage form (for example, “cream,” “gel,” “lotion,” or “ointment”).

Additionally, Sonage Acne Control Therapy is misbranded within the meaning of section 502(c) of the FD&C Act, 21 U.S.C. 352(c), because the label fails to bear an expiration date as required by 21 CFR 211.137. OTC drug products that do not bear dosage limitations and are stable for at least 3 years, as supported by appropriate stability data, are exempt from including an expiration date on their product label (21 CFR 211.137(h)). However, your product is not exempt from this requirement because it does not have 3-year stability data and therefore requires an expiration date.

  • Sonage Acne Control Therapy is also misbranded under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1), because the product label does not include all the applicable directions for use as required under 21 CFR 333.350(d). For example, the directions for use section for Sonage Acne Control Therapy does not include, “[bullet]clean the skin thoroughly before applying this product [bullet] cover the entire affected area with a thin layer one to three times daily [bullet] because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor [bullet] if bothersome dryness or peeling occurs, reduce application to once a day or every other day,” as required by 21 CFR 333.350(d)(1); and “[bullet] if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor,” as required by 21 CFR 333.350(d)(2)(i) and (ii).

The introduction or delivery for introduction of a misbranded drug into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a). Therefore, the marketing of Sonage Acne Control Therapy violates this provision of the FD&C Act.

Sonage Presage Moisturizer SPF15 Broad Spectrum UVA/UVB

Sonage Presage Moisturizer SPF15 Broad Spectrum UVA/UVB is a “drug” as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body. Specifically, this product is intended as a sunscreen drug product.

Examples of claims observed on your product label that establish the intended uses of the product as defined in 21 CFR 201.128 include, but may not be limited to, the following:

Label Claims:

“…Sonage Presage Moisturizer SPF15 Broad Spectrum UVA/UVB…”

The labeling for such drugs, as with all OTC drugs, must comply with all the requirements of section 502 of the FD&C Act and all pertinent regulations found in 21 CFR. However, your product does not meet these requirements for the reasons described below.

Sonage Presage Moisturizer SPF15 Broad Spectrum UVA/UVB is misbranded under section 502(c) of the FD& Act, 21 U.S.C. 352(c), for multiple reasons. Specifically, the product is misbranded within the meaning of section 502(c) of the FD&C Act, 21 U.S.C. 352(c), because the label fails to bear a statement of identity as required under 21 CFR 201.61. In the case of a mixture that does not have an established name, the statement of identity must contain a statement of the general pharmacological action(s) or principal intended action(s) of the mixture in the principal display panel. The label for this product fails to include the general pharmacological action(s) or principal intended action(s) of the product. Specifically, the label fails to include “sunscreen” on the product’s principal display panel.

  • Sonage Presage Moisturizer SPF15 Broad Spectrum UVA/UVB is also misbranded within the meaning of section 502(a) of the FD&C Act, 21 U.S.C. 352(a), because the label states under the “Uses” section, “continued use reduces the risk of skin cancer.” Therefore, this product is misbranded because any labeling that suggests or implies that the use, alone, of any sunscreen reduces the risk of or prevents skin cancer or early skin aging will cause the product to be misbranded as described in 21 CFR 201.327(c)(3).
  • Sonage Presage Moisturizer SPF15 Broad Spectrum UVA/UVB is misbranded within the meaning of section 502(c) of the FD&C Act, 21 U.S.C. 352(c), because the label fails to bear an expiration date as required by 21 CFR 211.137. OTC drug products that do not bear dosage limitations and are stable for at least 3 years, as supported by appropriate stability data, are exempt from including an expiration date on their product label (21 CFR 211.137(h)). However, your product is not exempt from this requirement because it does not have 3-year stability data and therefore requires an expiration date.
  • Sonage Presage Moisturizer SPF15 Broad Spectrum UVA/UVB is not labeled in accordance with the “Drug Facts” labeling requirements described in 21 CFR 201.66 and 21 CFR 201.327. Specifically, the product label fails to include “Other information,” as required by 21 CFR 201.327(f). Therefore, this product is misbranded under section 502(c) of the FD&C Act, 21 U.S.C. 352(c), because the information that is required to appear on the labeling is not prominently placed thereon with such conspicuousness and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
  • Sonage Presage Moisturizer SPF15 Broad Spectrum UVA/UVB is misbranded under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1), because the product label does not include all the applicable directions for use as required under 21 CFR 201.327(e). For example, the directions for use section for Sonage Presage Moisturizer SPF15 Broad Spectrum UVA/UVB does not include “[bullet] apply [select one of the following: ‘Liberally’ or ‘generously’] [and, as an operation: ‘And evenly’] 15 minutes before sun exposure, [bullet] reapply at least every 2 hours [bullet] use a water-resistant sunscreen if swimming or sweating,” as required by 21 CFR 201.327(e)(1)(ii) and (e)(4).
  • Sonage Presage Moisturizer SPF15 Broad Spectrum UVA/UVB is misbranded under section 502(f)(2) of the FD&C Act, 21 U.S.C. 352(f)(2), because the product label does not include all the applicable warnings as required under 21 CFR 201.327(d). For example, the warnings fail to list “Do not use [bullet] on damaged or broken skin,” as required by 21 CFR 201.327(d)(1).

The introduction or delivery for introduction of a misbranded drug into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a). Therefore, the marketing of Sonage Presage Moisturizer SPF15 Broad Spectrum UVA/UVB violates this provision of the FD&C Act.

Sonage Protect Plus Natural SPF 30 Broad Spectrum UVA/UVB

Sonage Protect Plus Natural SPF 30 Broad Spectrum UVA/UVB is a “drug” as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body. Specifically, this product is intended as a sunscreen drug product.

Examples of claims observed on your product label that establish the intended uses of the product as defined in 21 CFR 201.128 include, but may not be limited to, the following:

Label Claims:

“…Sonage Protect Plus Natural SPF 30 Broad Spectrum UVA/UVB. . . “

The labeling for such drugs, as with all OTC drugs, must comply with all of the requirements of section 502 of the FD&C Act and all pertinent regulations found in 21 CFR. However, your product does not meet these requirements for the reasons described below.

Sonage Protect Plus Natural SPF 30 Broad Spectrum UVA/UVB is misbranded within the meaning of section 502(c) of the FD&C Act, 21 U.S.C. 352(c), because the label fails to bear an expiration date as required by 21 CFR 211.137. OTC drug products that do not bear dosage limitations and are stable for at least 3 years, as supported by appropriate stability data, are exempt from including an expiration date on their product label (21 CFR 211.137(h)). However, your product is not exempt from this requirement because it does not have 3-year stability data and therefore requires an expiration date.

The introduction or delivery for introduction of a misbranded drug into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a). Therefore, the marketing of Sonage Protect Plus Natural SPF 30 Broad Spectrum UVA/UVB violates this provision of the FD&C Act.

Conclusion

Violations cited in this letter are not intended as an all-inclusive list. You are responsible for investigating these violations, for determining the causes, for preventing their recurrence, and for preventing other violations.

Correct the violations cited in this letter promptly. Failure to promptly correct these violations may result in legal action without further notice including, without limitation, seizure and injunction. Unresolved violations in this warning letter may also prevent other Federal agencies from awarding contracts.

Until these violations are corrected, we may withhold approval of pending drug applications listing your facility. We may re-inspect to verify that you have completed your corrective actions.

After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done since our inspection to correct your violations and to prevent their recurrence. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.

Send your electronic reply to ORAPharm4_responses@fda.hhs.gov or mail your reply to:

CDR Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV
U.S. Food & Drug Administration
19701 Fairchild Road
Irvine, California 92612-2506

Please identify your response with unique identifier 564038.

If you have any questions regarding any issues in this letter, please contact Maria P. Kelly-Doggett, Compliance Officer, via email to maria.kelly-doggett@fda.hhs.gov or by phone at (425) 302-0427 and reference unique identifier 564038.

Sincerely,
/S/

CDR Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV

 
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