Time-Cap Laboratories, Inc. – FDA EIR, Dec 18, 2019

An FDA inspection of Time-Cap Laboratories, Inc., a manufacturer of human over-the-counter (OTC), prescription drug products, and dietary supplements in Farmingdale, NY, was conducted from December 5 to December 18, 2019. This comprehensive Good Manufacturing Practices (GMP) surveillance inspection, carried out under the US Food, Drug & Cosmetic Act, identified significant concerns documented in an FDA-483 form with three observations.The primary violations included: (1) inadequate cleaning validation processes for manufacturing and packaging equipment. The company failed to ensure cross-contamination prevention when sharing equipment between drug products and dietary supplements, and did not properly evaluate cleaning agents. (2) A lack of written procedures governing the Quality Control Unit’s responsibilities, particularly regarding the validation of GMP software systems, appropriate user access controls, data integrity protection, and documentation of testing activities. This was a repeat observation from a previous inspection. (3) Failure to review unexplained discrepancies.Additional issues discussed included the firm's historical practice of reworking finished drug products without identifying root causes (though the firm claimed this practice ceased in April 2019), undocumented missed stability testing time points, and an inadequately qualified tableting press. Management, including the Managing Director & CEO, committed to addressing these observations and submitting a written response to the Agency within 15 business days.