What happened
FDA states that its review of records submitted by TSP Solutions identified significant CGMP violations involving sunscreen drug products. The firm did not demonstrate adequate finished-product testing before release. Submitted certificates of analysis and batch records lacked appropriate assays for active ingredient content, impurity testing, and appropriate microbiological testing. FDA also found that the firm did not demonstrate adequate identity testing of incoming components and accepted supplier certificates of analysis without verifying test results at appropriate intervals. Component quality verification consisted only of reviewing supplier certificates and material safety data sheets. In addition, FDA stated that the firm had not established an adequate quality unit with sufficient responsibilities and authority to oversee drug manufacturing. The quality unit failed to ensure adequate production and process control procedures, qualification of manufacturing equipment, laboratory control procedures, and an adequate ongoing stability program. FDA recommended a qualified CGMP consultant and a comprehensive six-system audit. The firm’s drugs were placed on Import Alert 66-40 on August 14, 2026.
Why it matters
From a pharmaceutical manufacturing perspective, the missing finished-product assays and microbiological testing may leave the firm without adequate scientific evidence that released sunscreen batches meet established specifications. Insufficient incoming-component identity testing and unverified supplier data may similarly permit unsuitable raw materials to enter production. FDA’s findings concerning quality unit authority, process controls, equipment qualification, laboratory procedures, and stability indicate broader weaknesses in oversight across the product lifecycle. Effective remediation would therefore need to address both specific testing gaps and the underlying quality system.
Key topics: Missing active ingredient, impurity, and microbiological release testing, Unverified supplier certificates and inadequate component identity testing, Inadequate quality unit oversight of controls, equipment, and stability