Private Label Skin Care, Inc.
FDA issued a warning letter to Private Label Skin Care, Inc. (Canoga Park, CA) following a June 2025 inspection that found significant CGMP violations and drug listing failures. The company, which uses a contract manufacturer, continued distributing OTC drug products with elevated impurities after being notified of the problem, and ultimately issued a voluntary recall. Additionally, the firm failed to provide required drug listings for at least 21 OTC drug products, rendering them misbranded under the FD&C Act. FDA demanded a written corrective action response within 15 working days and warned that failure to comply could result in seizure, injunction, or withholding of export certificates and new application approvals.
Flagged claims (7)
The Treatment On the Daily SPF 45
Pore Refining Cleanser 2% Salicylic Acid
Age Defense SPF 45
100% Mineral Tinted SPF
The Treatment Let's Get Physical Tinted SPF 44
Acne Clearing Serum
Healthy Glow Tinted BB Cream SPF 44+
Required actions (5)
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.
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.
A comprehensive assessment and remediation plan to ensure your QU is given the authority and resources to effectively function.
We may re-inspect to verify that you have completed corrective actions to address any violations.
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.
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