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WARNING LETTER

Colonial Dames Company, Ltd MARCS-CMS 659151 —


Delivery Method:
Via Email
Product:
Drugs

Recipient:
Recipient Name
Mr. Kort V. Pearson
Recipient Title
Chief Executive Officer
Colonial Dames Company, Ltd

6820 Watcher Street
Commerce, CA 90040
United States

kort@colonialdames.com
Issuing Office:
Division of Pharmaceutical Quality Operations IV

United States

Secondary Issuing Offices

United States


WARNING LETTER

December 5, 2023

Dear Mr. Pearson:

The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Colonial Dames Company, Ltd, FEI 2011035, at 6820 Watcher Street, Commerce, CA, from April 4 to 12, 2023.

This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (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).

In addition, your “oxygenetix® (b)(4)” and “oxygenetix® Oxygenating Foundation Acne Control” products are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of section 505(a) of the FD&C Act, 21 U.S.C. 355(a). Furthermore, “oxygenetix® (b)(4)” and “oxygenetix® Oxygenating Foundation Acne Control” products are also misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee). Introduction or delivery for introduction of such products into interstate commerce is prohibited under sections 301(d) and (a) of the FD&C Act, 331(d) and (a). These violations are described in more detail below.

Furthermore, Colonial Dames Company, Ltd, failed to fulfill its drug listing obligations under section 510(j)(1) of the FD&C Act, U.S.C. 360(j), which is a prohibited act under section 301(p) of the FD&C Act, 21 U.S.C. 331(p). In addition, the failure to properly list (b)(4) and Oxygenating Foundation Acne Control with the FDA also renders these drugs misbranded under section 502(o) of the FD&C Act, 21 U.S.C 352(o). Introduction or delivery for introduction of such a product 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 May 2, 2023, response to our Form FDA 483 in detail. Your response is inadequate because it only made general commitments, such as improving standard operating procedures (SOPs) and did not provide sufficient detail or evidence of corrective actions to bring your operations into compliance with CGMP.

Adulteration Violations

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

1. Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).

Your firm manufactures over-the-counter (OTC) topical acne drug products, including Oxygenetix Institute (b)(4) and Oxygenetix Institute Oxygenating Foundation Acne Control. Your acne drug product manufacturing records lacked critical parameters such as equipment identification, mixing speeds, mixing times, and component addition rates. For example, during the inspection, you told our investigators that a tape measure was used to determine the required amount of replacement water needed for your Oxygenetix Institute (b)(4) drug product upon loss of water by evaporation. Additionally, during the inspection, your firm failed to provide supporting documentation that your drug product manufacturing processes are validated, and that each step is controlled to assure that the finished product meets all quality attributes including specifications.

It is essential that you establish detailed batch instructions that address all sources of variability and enable ongoing state of control. Without adequate batch record specificity, you cannot assure the uniformity and reproducibility of your drug products from batch-to-batch.

Process validation evaluates the soundness of design and state of control of a process throughout its lifecycle. Each significant stage of a manufacturing process must be designed appropriately and ensure the quality of raw material inputs, in-process materials, and finished drugs. Failure to conduct these studies can result in product quality attribute failures. Process qualification studies determine whether an initial state of control has been established. Successful process qualification studies are necessary before commercial distribution. Thereafter, ongoing vigilant oversight of process performance and product quality is necessary to ensure that you maintain a stable manufacturing operation throughout the product lifecycle.

In response to this letter, provide:

  • A detailed summary of your validation program for ensuring a state of control throughout the product lifecycle, along with associated procedures. Describe your program for process performance qualification (PPQ), and ongoing monitoring of both intra-batch and inter-batch variation to ensure a continuing state of control.
  • A timeline for performing appropriate PPQ for each of your marketed drug products.
  • Include your process performance protocol(s), written procedures for qualification of equipment and facilities, and final reports.
  • Provide a detailed program for designing, validating, maintaining, controlling, and monitoring each of your manufacturing processes that includes vigilant monitoring of intra-batch and inter-batch variation to ensure an ongoing state of control. Also, include your program for qualification of your equipment and facility.
  • An assessment of each drug product process to ensure that there is a data-driven and scientifically sound program that identifies and controls all sources of variability, such that your production processes, will consistently meet appropriate specifications and manufacturing standards. This includes, but is not limited to, evaluating suitability of equipment for its intended use, sufficiency of detectability in your monitoring and testing systems, quality of input materials, and reliability of each manufacturing process step and control.
  • Timelines for completed PPQ for marketed drug products.

2. Your firm failed to clean, maintain, and sanitize and/or sterilize 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 beyond the official or other established requirements, and you failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(a) and (b)).

Your cleaning procedures were not supported by validation studies, and you did not maintain appropriate cleaning records. Your manufacturing utensils and containers were unclean with what appeared to be residue from previous use. These conditions were originally cited during the 2015 inspection, uncorrected during the 2021 inspection, and continue to persist. Chemical and microbiological residues on equipment from previous manufacturing activities can adversely impact the purity, quality, and safety of drug products also manufactured on that equipment.

Furthermore, these conditions extend to your raw material storage area, cleaning sink, and production area. These areas were observed to be in an unclean state and with disorderly placement of materials, which is inadequate to prevent contamination.

In response to this letter, provide a corrective action and preventative action (CAPA) plan, based on the retrospective assessment of your cleaning program, that includes appropriate remediations to your cleaning processes and practices, and timelines for completion. Provide a detailed summary of vulnerabilities in your process for lifecycle management of equipment cleaning. Describe improvements to your cleaning program, including enhancements to cleaning effectiveness; improved ongoing verification of proper cleaning execution for all products and equipment; and all other needed remediations.

3. Your firm failed to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance (21 CFR 211.63).

Your (b)(4) water system used to manufacture drug products (e.g., Oxygenetix Institute (b)(4)) was not designed and maintained appropriately for its intended use (i.e., cleaning, formulation). Your firm uses a (b)(4) water system that has not been appropriately qualified for use and failed to include appropriate monitoring or testing. Moreover, the accumulation of rust on the exterior of the water system’s holding tank since the last inspection was observed to be increasingly worse and indicates an ongoing maintenance issue (e.g., leak). The conditions of your water system were discussed during a regulatory meeting with your firm on November 10, 2021. As a result, in your response to the FDA dated December 3, 2021, your firm committed to purchasing (b)(4) water that meets United States Pharmacopeia (USP) standards from a qualified vendor. However, your firm continued to use the water from your unqualified water system for cleaning and product formulation.

In response to this letter, provide:

  • A comprehensive, independent assessment of your water system design, control, and maintenance.
  • A thorough remediation plan to install and operate a suitable water system. Include a robust ongoing control, maintenance, and monitoring program to ensure the new system consistently produces water adhering to (b)(4) monograph specifications, and appropriate microbial limits.
  • Regarding the latter, ensure that your total microbial count limit for water is appropriate in view of the intended use of the products produced by your firm.

4. Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).

Your quality unit (QU) did not provide adequate oversight for the manufacture of your drug products. Specifically, your QU failed to ensure appropriate:

  • Standard operating procedures
  • Validation plans (e.g., test methods, process validations)
  • Supplier qualification
  • Quality agreements
  • Annual product review (APR)
  • Customer Complaints

An adequate QU overseeing all manufacturing operations is necessary to consistently ensure drug quality. See the FDA’s guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations for help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR parts 210 and 211 at https://www.fda.gov/media/71023/download.

In response to this letter, provide:

  • A comprehensive assessment and remediation plan to ensure your QU is given the authority and resources to effectively function. The assessment should also include, but not be limited to:

    o A determination of whether procedures used by your firm are robust and appropriate.
    o Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices.
    o A complete and final review of each batch and its related information before the QU disposition decision.
    o Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products.

  • Describe how top management supports quality assurance and reliable operations, including, but not limited to, timely provision of resources to proactively address emerging manufacturing/quality issues and to assure a continuing state of control.
  • A comprehensive, independent assessment of your overall system for investigating deviations, discrepancies, complaints, out-of-specification (OOS) results, and failures. Provide a detailed action plan to remediate this system. Your action plan should include, but not be limited to, significant improvements in investigation competencies, scope determination, root cause evaluation, CAPA effectiveness, QU oversight, and written procedures. Address how your firm will ensure all phases of investigations are appropriately conducted.

5. Your firm failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)).

Your firm does not have adequate stability data to show that the chemical and microbiological properties of your topical acne drug products for OTC human use remain acceptable throughout the labeled expiry period of 3 years, for example:

  • Chemical test data for your Oxygenetix Institute Oxygenating Foundation Acne Control drug product exceeded the monograph acceptance criteria of (b)(4) increase at expiry for the active ingredient salicylic acid. While your firm could not provide an investigation for the OOS during the inspection, you state in your response that the increase was due to evaporation, and that measures have been taken to address the issue. However, you did not provide a detailed investigation identifying the root cause for the evaporation, nor supporting data to assure your CAPA is adequate.
  • You failed to ensure microbiological test methods used by your contract testing laboratory (CTL) in your stability program were validated (or verified). Specifically, test methods referenced by your CTL are microbiological test methods intended for analyses of foods and cosmetics. Drug products must be tested using appropriate microbiological quality standards including total count and objectionable microorganisms. This may include, but not be limited to, applicable USP general chapters. It is essential to ensure that each of your finished drug products conform to appropriate microbiological specifications before release and throughout the drug product’s life cycle.

We discussed these issues with you during the 2021 regulatory meeting.

  • Furthermore, your stability test data lacks appropriate evaluation of your drug products’ antimicrobial effectiveness throughout its life cycle.

Without appropriate stability data, you cannot ensure your drug products meet established specifications and all pre-determined quality criteria throughout the assigned shelf-life of your drug products.
In response to this letter, provide:

  • A comprehensive, independent assessment and CAPA plan to ensure the adequacy of your stability program. Your remediated program should include, but not be limited to:

    o Stability indicating methods.
    o Stability studies for each drug product in its marketed container-closure system before distribution is permitted.
    o An ongoing program in which representative batches of each product are added each year to the program to determine if the shelf-life claim remains valid.
    o Detailed definition of the specific attributes to be tested at each station (timepoint).

  • All procedures that describe these and other elements of your remediated stability program.
  • Appropriate scientific studies to evaluate antimicrobial effectiveness testing (AET) for your aqueous multi-dose drug product. AET by USP <51> testing should be performed at a range of preservative concentrations and should be inclusive of concentrations at or below that listed in the formulation for each drug product. In addition to initial USP <51> studies on your formulations, one of the primary batches of the drug product should be tested for antimicrobial preservative effectiveness (in addition to preservative content) at the end of the proposed shelf life. The drug product specification should include a test for preservative content, and this attribute should be tested in all stability studies.

Unapproved New Drug and Misbranding Violations

“oxygenetix® (b)(4)” and “oxygenetix® Oxygenating Foundation Acne Control” are “drugs” as defined by section 201(g)(1)(B) of the Food, Drug and Cosmetic Act (FD&C Act,) 21 U.S.C. 321(g)(1)(B), because they are intended for the use in 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 they are intended to affect the structure or any function of the body. Specifically, these products are intended for the treatment of acne.

Examples of claims observed on the “oxygenetix® (b)(4)” and “oxygenetix® Oxygenating Foundation Acne Control” product labeling, including your website, https://www.oxygenetix.com, where products are available for purchase, that provide evidence of the intended uses (as defined in 21 CFR 201.128) of your products as a drug include, but may not be limited to the following:

“oxygenetix® (b)(4)
“Oxygenating Hydro-Matrix . . . (37% ceravitae complex) . . . Acne Control . . . anti-inflammatory . . . antimicrobial . . . DRUG FACTS . . . USES: . . . TREATS ACNE, HELPS PREVENT DEVELOPMENT OF NEW ACNE BLEMISHES” [from your product label and outer carton]

“CERAVITAE COMPLEX . . . Ceravitae allows your skin to absorb more oxygen, stimulating skin cell production and helping to heal.” [from your website https://www.oxygenetix.com/products/acne-control-hydro-matrix]

Oxygenating Foundation Acne Control”
“Acne Control . . . ceravitae pro-oxygen complex . . . DRUG FACTS . . . USES: . . . TREATS ACNE, HELPS PREVENT DEVELOPMENT OF NEW ACNE BLEMISHES” [from your product label]

“Oxygenating Acne Control Foundation clears not causes acne, giving you confidence even on your worst skin days. And the aloe vera base, instead of water or oils that attract bacteria to your skin, is antibacterial and soothing.” [from your website https://www.oxygenetix.com/products/oxygenetix-acne-control-foundation]

“Oxygenating Acne Control contains 2% time-release salicylic acid . . . Oxygenetix Acne Control gets applied to the surface epidermis of the skin where it has the highest concentration, then it diffuses over time throughout the skin. This time release system works to ensure the salicylic acid kills acne-causing bacteria and reduces inflammation throughout the day.” [from your website https://www.oxygenetix.com/blogs/blog/salicylic-acid-your-best-weapon-in-the-fight-against-acne]

“Ceravitae® is the Oxygenetix patented hero ingredient, a potent derivative from Saccharomyces Lysate, a yeast compound with pro-healing properties. Ceravitae® promotes oxygen uptake to skin cells which in turn accelerates tissue growth.”
[from your website https://www.oxygenetix.com/blogs/blog/ceravitae%C2%AE-the-oxygenetix-hero-ingredient?_pos=1&_sid=054fbb2cb&_ss=r]

Unapproved New Drug Violations

Based on the above labeling claims, “oxygenetix® (b)(4)” and “oxygenetix® Oxygenating Foundation Acne Control” are intended for use as OTC topical acne drugs. As described below, these drug products are unapproved new drugs marketed in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C 355(a) and 331(d).

A drug product is a “new drug” within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), if it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its labeling; and in general, new drugs may not be introduced or delivered for introduction into interstate commerce without an approved application from the FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for the two products identified above.

Your “oxygenetix® (b)(4)” and “oxygenetix® Oxygenating Foundation Acne Control” products are acne drug products subject to section 505G of the FD&C Act, 21 U.S.C. 355h, which governs nonprescription drugs marketed without an approved application. Under section 505G of the FD&C Act, certain nonprescription drugs without an approved application—commonly referred to as “OTC monograph drugs”—may be legally marketed if they meet applicable requirements. With respect to OTC topical acne drug products, they must, among other things, conform to the conditions of use specified in the Over-the-Counter Monograph M006: Topical Acne Drug Products for Over-the-Counter Human Use (hereinafter referred to as “M006” or “the topical acne drug products monograph”).1 As described below, your “oxygenetix® (b)(4)” and “oxygenetix® Oxygenating Foundation Acne Control” drug products are unapproved new drugs marketed in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C 355(a) and 331(d).

Your product labeling for “oxygenetix® (b)(4)” and “oxygenetix® Oxygenating Foundation Acne Control” represents the ingredients, (b)(4) and aloe vera, as active ingredients, which, under 21 CFR 201.66(b)(2), means any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of humans. Although your firm does not specifically list (b)(4) or aloe vera as an active ingredient in the Drug Facts Panels for “oxygenetix® (b)(4)” and “oxygenetix® Oxygenating Foundation Acne Control,” your website claims for these specific ingredients, such as “(b)(4) is the Oxygenetix patented hero ingredient, a potent derivative from Saccharomyces Lysate, a yeast compound with pro-healing properties” and “using a unique aloe vera base, this foundation is both antibacterial and soothing” demonstrate that these are “active ingredients” as defined in 21 CFR 201.66(b)(2) because they are intended to furnish pharmacological activity. Neither (b)(4) nor aloe vera is permitted as an active ingredient in M006.

Further, your “oxygenetix® (b)(4)” and “oxygenetix® Oxygenating Foundation Acne Control” product labeling includes indications that are not consistent with the topical acne products monograph indications. For example, the website claims that the products provide “pro-healing properties,” “accelerates tissue growth,” and that the products have antibacterial properties, do not conform with M006 in that they go beyond merely describing the general intended uses for topical acne drug products.

Further, your “oxygenetix® (b)(4)” and “oxygenetix® Oxygenating Foundation Acne Control” products are labeled to contain time-release claims for salicylic acid. Specifically, your website includes the following claims, “Oxygenating Acne Control contains 2% time-release salicylic acid . . . Oxygenetix Acne Control gets applied to the surface epidermis of the skin where it has the highest concentration, then it diffuses over time throughout the skin. This time-release system works to ensure the salicylic acid kills acne-causing bacteria and reduces inflammation throughout the day.” A timed-release dosage form requires an NDA under 21 CFR 310.502(a)(14). However, as previously noted, neither your “oxygenetix® (b)(4)” nor “oxygenetix® Oxygenating Foundation Acne Control” products are the subject of an FDA approved application.

For the reasons described above, “oxygenetix® (b)(4)” and “oxygenetix® Oxygenating Foundation Acne Control” are unapproved new drugs marketed in violation of sections 505(a) of the FD&C Act, 21 U.S.C 355(a). These products do not comply with M006, Topical Acne Drug Products for Over-the-counter Human Use, as set forth in final administrative order OTC000013, nor do they comply with any other final order.2 No FDA-approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for these drug products. Accordingly, as “oxygenetix® (b)(4)” and “oxygenetix® Oxygenating Foundation Acne Control” are unapproved new drugs. The introduction or delivery for introduction of such products into interstate commerce is prohibited under sections 301(d) of the FD&C Act, 21 U.S.C. 331(d).

Misbranded Drug Violations

Your, “oxygenetix® (b)(4)” and “oxygenetix® Oxygenating Foundation Acne Control” are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because both products are nonprescription drugs subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but do not comply with the requirements for marketing under that section and are not the subject of applications approved under section 505 of the FD&C Act, 21 U.S.C. 355.

The introduction or delivery for introduction of a misbranded drug into interstate commerce violates section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

Under section 510of the FD&C Act, 21 U.S.C 360 and 21 CFR Part 207, all drugs manufactured, prepared, propagated, compounded, or processed for U.S. commercial distribution must be listed with the FDA. Additionally, under section 510(j)(2) of the FD&C Act, 21 U.S.C. section 360(j)(2), and 21 CFR 207.57(b)(2), registrants are required to submit updated drug listing information to the FDA twice each year, in June and December, notifying the FDA if this information has changed. Under 21 CFR 207.29(b) registrants may satisfy the listing update requirement with respect to unchanged listing information by making a single “no changes” certification during the annual October-December annual registration period.

A review of the FDA’s drug registration and listing database determined that your current establishment registration does not show your (b)(4) product as being listed and the drug listing submission for Oxygenating Foundation Acne Control was inactivated by the FDA because it was not certified to be current under 21 CFR 207.57(b)(2) or21 CFR 207.29(b). Since both drugs are currently available in the U.S. market while not properly listed, your firm has not fulfilled its listing obligations under section 510(j) of the FD&C Act, 21 U.S.C 360(j), which is a prohibited act under section 301(p) of the FD&C Act, 21 U.S.C. 331(p). In addition, failure to properly list these drugs with the FDA renders them misbranded under section 502(o) of the FD&C Act, 21 U.S.C 352(o).

Introduction or delivery for introduction of such products into interstate commerce is prohibited under section 301(a) of the FD&C Act, 331(a).

Center for Food Safety and Applied Nutrition Concerns

In addition, we note that some of the products you manufacture may be regulated as cosmetics, as defined in section 201(i) of the FD&C Act. A cosmetic may be deemed adulterated under section 601(c) of the FD&C Act, 21 U.S.C. 361(c), if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. Some of the sanitation conditions that cause the drug products you manufacture to be adulterated may also cause any cosmetic products you manufacture to be adulterated. We note that under section 301(a) of the FD&C Act, 21 U.S.C. 331 (a), it is a prohibited act to introduce or deliver for introduction into interstate commerce a cosmetic product that is adulterated.

Repeat Observations at Facility

In previous inspections, dated June 22 to 25, 2015, and April 27 to 29, 2021, the FDA cited similar CGMP observations. Additionally, a regulatory meeting was held with your firm on November 10, 2021, to discuss your observations. You proposed specific remediation for these observations in your response. Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate.

CGMP Consultant Recommended

Based upon the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 to assist your firm in meeting CGMP requirements. The qualified consultant should also perform a comprehensive six-system audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of all CAPAs before you pursue resolution of your firm’s compliance status (i.e., Quality System, Facilities & Equipment System, Materials System, Production System, Packaging & Labeling System, and Laboratory Control System).

Conclusion

The 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 any violations and for preventing their recurrence or the occurrence of other violations.

Correct any violations promptly. Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure, and injunction. Unresolved violations may also prevent other Federal agencies from awarding contracts.

Failure to address violations may also cause the FDA to withhold issuance of Export Certificates. The FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any violations.

This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.

Please 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 and Drug Administration
19701 Fairchild Road
Irvine, CA 92612-2506

Please identify your responses with the unique identifier: CMS 659151.

If there are any questions about the released information, please contact Yumi Hiramine, compliance officer, at Yumi.Hiramine@fda.hhs.gov or at 818-226-1839.

Sincerely,
/S/

CAPT Katherine Jacobitz
Acting Director, Division of Pharmaceutical Quality Operations IV

_____________________

1 Section 505G(a)(1) of the FD&C Act specifies criteria under which certain nonprescription drugs without an approved application are deemed GRASE and not "new drugs," notably, conformance with conditions detailed in applicable OTC monograph documents issued by the FDA under 21 CFR part 330 prior to enactment of the CARES Act. In the case of OTC topical acne drugs, relevant documents were deemed under section 505G to be a final administrative order, Over-the-Counter Monograph M006: Topical Acne Drug Products for Over-the-Counter Human Use (See Order ID OTC000013, available at the FDA’s website OTC Monographs@FDA, https://dps.fda.gov/omuf).

2 The FDA is also not aware of any adequate and well-controlled clinical trials in the published literature that support a determination that “oxygenetix® (b)(4)” and “oxygenetix® Oxygenating Foundation Acne Control” are GRASE for use under the conditions prescribed, recommended, or suggested in their labeling.

 
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