FDA WARNING_LETTER - Lloyd Inc. of Iowa - April 16, 2013

An FDA inspection of Lloyd Inc. of Iowa from March 18 to April 16, 2013, revealed significant Current Good Manufacturing Practice (CGMP) violations for Finished Pharmaceuticals (21 CFR Parts 210 and 211) in their animal drug manufacturing, rendering products adulterated under section 501(a)(2)(B) of the Act. Key deficiencies included failure to justify component overages in master production records for Levothyroxine products, lack of process validation studies for all strengths, and inconsistent in-process and final specifications. The firm also failed to ensure representative in-process sampling. Critical quality system failures involved inadequate complaint handling, with numerous consumer complaints uninvestigated, and the Quality Control Unit failing to conduct or document necessary investigations (21 CFR §§ 211.198(a), 211.198(b)(3)). Furthermore, the firm did not thoroughly investigate unexplained discrepancies like recalled lots, OOS reports, and stability failures (21 CFR § 211.192), nor did it complete required annual product reviews (21 CFR § 211.180(e)). The FDA highlighted a decade of repeated quality system deficiencies, indicating a lack of sustainable corrective actions. The firm recalled affected Levothyroxine lots and plans to cease manufacturing certain products. The FDA deemed the firm's responses insufficient, demanding a comprehensive written response within 15 working days detailing specific, documented corrective actions and a timetable to prevent enforcement actions such as seizure or injunction.