FDA WARNING_LETTER - KVK Tech, Inc. - March 13, 2020

The FDA issued a Warning Letter to KVK-Tech, Inc. following an inspection from February 4 to March 13, 2020, at their Newtown, PA drug manufacturing facility. The inspection revealed significant violations of current Good Manufacturing Practice (CGMP) regulations, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. **Failure to establish and follow adequate written procedures for equipment cleaning and maintenance (21 CFR 211.67(b))**: The firm did not validate cleaning processes for non-dedicated packaging equipment (slat counter) as required by their SOP, leading to potential cross-contamination. The FDA found their response inadequate, citing issues with worst-case scenario identification, lack of swab sites in slat cavities, and insufficient explanation for deviating from SOPs. Required actions include improving cleaning validation, identifying worst-case conditions (e.g., drug toxicity, solubility, difficult-to-clean areas), and revising change management for new equipment/products. 2. **Failure to prepare complete batch production and control records (21 CFR 211.188)**: Investigators observed inaccurate air pressure gauge readings recorded in batch records and unrecorded deviations during packaging operations. The firm's response was deemed inadequate for not conducting a comprehensive review of data recording issues or providing a plan for improved management oversight