FDA WARNING_LETTER - Clover Custom Blending LLC - May 17, 2017

The FDA inspected Clover Custom Blending LLC from May 15-17, 2017, identifying significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering drug products adulterated (21 U.S.C. 351(a)(2)(B)) and one product misbranded (21 U.S.C. 352(c)). Key deficiencies included the firm's failure to thoroughly investigate out-of-specification (OOS) results for sunscreen lotion (21 CFR 211.192), such as super-potent and sub-potent active ingredients, before product release. The quality control unit lacked established written responsibilities and procedures for critical operations like training, batch record completion, recalls, complaints, deviations, and investigations (21 CFR 211.22(d)). The facility also failed to maintain adequate separate areas, using shared equipment for OTC drugs and industrial products, leading to potential cross-contamination, with observations of flaking paint and unknown residues (21 CFR 211.42(c)). Furthermore, the firm did not conduct identity testing for each drug component or validate supplier analyses (21 CFR 211.84(d)(1)&(2)). The Bulk SPF 30 Sunscreen Tote was deemed misbranded because its outer container labeling lacked required "Drug Facts" (21 CFR 201.66). The FDA deemed the firm's initial response inadequate and strongly recommended engaging a CGMP consultant. Clover Custom Blending must promptly correct these violations, provide comprehensive corrective and preventive action plans, and conduct risk assessments for affected products within 15 working days to avoid further legal action, including seizure, injunction, and impact on drug approvals or export certificates.