Warning Letter — Spa De Soleil, Inc.
The FDA issued a Warning Letter to Spa De Soleil, Inc. following an inspection by the Center for Drug Evaluation and Research (CDER). The letter identifies compliance failures at the firm's manufacturing facility.
This affects Spa De Soleil, Inc., its contract manufacturing partners, and personnel responsible for CGMP compliance, drug manufacturing, and quality oversight.
While the source does not list specific technical violations, the issuance of a CDER Warning Letter indicates significant deviations from Current Good Manufacturing Practice (CGMP). This suggests potential risks to product quality and may lead to regulatory actions such as import alerts or withholding of product approvals if deficiencies are not remediated. Regulatory teams should view this as a signal of heightened agency scrutiny regarding the firm's quality management systems.
Quality and regulatory teams should conduct a thorough review of existing manufacturing protocols and quality control systems to ensure alignment with CGMP standards. Immediate attention to documentation accuracy and facility maintenance is recommended until the specific violations are addressed.
FDA Warning Letter issued to: Spa De Soleil, Inc.. 07/08/2026 — Center for Drug Evaluation and Research (CDER). Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/spa-de-soleil-inc-728508-07082026
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