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Warning Letter 320-26-30

December 18, 2025

Dear Mr. Raoof:

The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Private Label Skin Care, Inc., FEI 3015274499, at 8200 Remmet Ave., Canoga Park, CA, from June 16 to 23, 2025.

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, we reviewed your firm’s drug listing submissions in FDA’s electronic Drug Registration and Listing System (eDRLS) and found that you have not provided drug listings for at least 21 of your human over-the-counter (OTC) drugs as required by section 510(j) of the FD&C Act.

Your firm has not fulfilled its drug listing obligations under section 510(j) of the FD&C Act, 21 U.S.C. 360(j), and 21 CFR Part 207, which is prohibited under section 301(p) of the FD&C Act, 21 U.S.C. 331(p), and will render a drug misbranded under section 502(o) of the FD&C Act, 21 U.S.C. 352(o). 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). In addition, failure to list a drug is prohibited under section 301(p) of the FD&C Act, 21 U.S.C. 331(p). These violations are described in more detail below.

CGMP Violations

We reviewed your July 15, 2025, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondences.

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

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 and the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated (21 CFR 211.22(a)).

You are the owner and labeler of numerous OTC drug products. Your firm uses a contract manufacturing organization (CMO) to perform various CGMP activities on your behalf. As the owner of the products, you were informed by your CMO of the elevated (b)(4) impurities in your (b)(4). After your CMO notified your firm of the elevated (b)(4) impurities, your firm continued distribution of identified batches of (b)(4).

On August 25, 2025, FDA held a teleconference with you recommending that you consider removing adulterated batches of (b)(4) currently in distribution from the U.S. market. On (b)(4), you issued a voluntary recall of the adulterated batches of (b)(4) currently in distribution from the U.S. market due to elevated levels of (b)(4) that were discovered with (b)(4) products.

In your response, you commit to incorporating (b)(4) testing into your release specifications and stability studies for all products containing (b)(4), assessing component suppliers of active ingredients and excipients for (b)(4) formulation and content, and exploring formulation changes that reduce or eliminate (b)(4) formation risks. Your response is inadequate. Your quality unit (QU) failed to determine the impact to other batches of (b)(4) products as well as other products containing (b)(4) that were previously released and remain on the market within expiry.

When you use a CMO for all or part of the manufacturing of a drug product, your QU is responsible for approving or rejecting the CMO’s products and services, including the suitability of releasing batches for commercial distribution. An adequate QU overseeing all manufacturing operations is necessary to consistently ensure drug quality. See 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.

Regarding drug products containing (b)(4), FDA has alerted drug manufacturers of products at risk for presence of (b)(4). For more information see (b)(4)

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.
• A summary of all results obtained from testing retain samples from each batch of (b)(4) products that are currently on the U.S. market within expiry. If the testing reveals substandard quality drug products, take rapid corrective actions, such as notifying customers and product recalls.

Use of Contract Manufacturers

Drugs must be manufactured in conformance with CGMP. FDA is aware that many drug manufacturers use independent contractors such as production facilities, testing laboratories, packagers, and labelers. FDA regards contractors as extensions of the manufacturer.

You are responsible for the quality of your drugs regardless of agreements in place with your contract facilities. You are required to ensure that drugs are made in accordance with section 501(a)(2)(B) of the FD&C Act to ensure safety, identity, strength, quality, and purity. See FDA guidance document Contract Manufacturing Arrangements for Drugs: Quality Agreements at https://www.fda.gov/media/86193/download.

Drug Listing Violations

Section 510(j) of the FD&C Act, 21 U.S.C. 360(j), and 21 CFR Part 207 set forth the requirements for drug listing. Specifically, under section 510(j)(1) of the FD&C Act and 21 CFR 207.41(a), each registrant must list each drug that it manufactures, repacks, relabels, or salvages for commercial distribution. Further, under 21 CFR 207.53, each registrant must provide required listing information for each drug it repacks or relabels. Your firm has failed to provide drug listings for the following drugs:

“Age Defense SPF 45,” “The Treatment On the Daily SPF 45,” “100% Mineral Tinted SPF,” “Healthy Glow Tinted BB Cream SPF 44+,” “The Treatment Let’s Get Physical Tinted SPF 44,” “Dermlogic Anti-Aging Resurfacing Peel Pads,” “Even GLO Brightening Pads,” “Physical Daily Defense SPF 40,” “Acne Clearing Serum,” “Matte Tinted SPF,” “Fresh Faced Tinted SPF 44,” “Hydralite Moisturizer,” “Pigment Correcting Pads,” “Bye, Bye Blemish,” “Papaya Enzyme Cleanser,” “Clear Defense SPF 45,” “Detox Mask,” “Pore Refining Cleanser 2% Salicylic Acid,” “Sheer Defense Tinted SPF 46,” “Hydro Essence SPF 40,” and “Micro Peel Pads” (collectively, "your firm’s OTC drugs”)

Therefore, your firm’s OTC drugs are not properly listed under section 510(j) of the FD&C Act, 21 U.S.C. 360(j), rendering these drugs misbranded under section 502(o) of the FD&C Act, 21 U.S.C. 352(o). 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). Additionally, failure to list a drug is prohibited under section 301(p) of the FD&C Act, 21 U.S.C. 331(p).

Complete, accurate, and up-to-date establishment registration and drug listing information is essential for promoting and protecting patient safety. The FDA relies on this information for several critical programs, including drug establishment inspections, supply chain security, and post-market surveillance. Additionally, establishment registration and drug listing data are extensively utilized outside the FDA for purposes such as electronic prescribing systems, electronic health records, insurance reimbursement processes, and patient education initiatives.

It is your responsibility to ensure that all drugs manufactured at your establishment comply with establishment registration and drug listing requirements under section 510 of the FD&C Act, 21 U.S.C. 360, 21 CFR Part 207, and all other applicable FDA regulations. Registration and listing information, along with instructions on how to properly register an establishment or submit drug listings can be found at https://www.fda.gov/drugs/electronic-drug-registration-and-listing-system-edrls/electronic-drug-registration-and-listing-instructions.

Cosmetic Manufactured for Distribution in the United States

In addition, some of the products you distribute may be regulated as cosmetics, as defined in section 201(i) of the FD&C Act [21 U.S.C. 321(i)]. Any cosmetics you distribute must comply with applicable statutory and regulatory requirements, including the FD&C Act. 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 that is adulterated or misbranded.

Further, your facility may be subject to requirements under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). You may find the FD&C Act, MoCRA, and FDA’s regulations through links on FDA’s website at www.fda.gov.

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 FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your firm as a 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.

Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3015274499 and ATTN: Paul Z. Balcer.

Sincerely,
/S/

Francis Godwin
Director
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research
 

/S/

Tina Smith
Captain, U.S. Public Health Service
Director
Office of Unapproved Drugs & Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research