The US FDA has sent a warning letter to Private Label Skin Care, Inc., Canoga Park, CA.

FDA conducted an inspection from June 16-23, 2025 where it found significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals.

In the Dec. 18, 2025 letter, FDA said the 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.

FDA’s letter states: “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).”

FDA held a teleconference with the company in August 2025 during which the Agency recommended that Private Label Skin Care, Inc. consider removing adulterated batches currently in distribution from the US market. The company issued a voluntary recall of the adulterated batches of currently in distribution from the US. According to FDA, in its response, Private Label Skin Care, Inc. committed to incorporating testing into its release specifications and stability studies for all products, assessing component suppliers of active ingredients and excipients, and exploring formulation changes that reduce or eliminate formation risks.

FDA, in the letter, said the company’s response was inadequate, noting that the the quality unit (QU) failed to determine the impact to other batches products as well as other products containing the materials noted that were previously released and remain on the market within expiry.

In the letter, FDA stated: “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.”

FDA said it also reviewed the company’s drug listing submissions in FDA’s electronic Drug Registration and Listing System (eDRLS) and found that the company had not provided drug listings for at least 21 of its over-the-counter (OTC) drugs as required by section 510(j) of the FD&C Act.  According to FDA, the firm failed to provide drug listings for: 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.