Loading…
SV Labs Corporation's Prescott, Wisconsin facility manufactured adulterated veterinary and over-the-counter human drug products due to significant Current Good Manufacturing Practice (CGMP) violations, specifically failing to thoroughly investigate out-of-specification test results before releasing products to customers. The company released an SPF 30 sunscreen lotion lot that failed microbial testing with a "too numerous to count" result without conducting proper root cause investigation, and this represented a repeat violation as the firm had previously been cited for the same non-compliance during an earlier FDA inspection. The violations violated 21 CFR 211.192 requirements for batch investigation and rendered the drug products adulterated under the Federal Food, Drug, and Cosmetic Act.