FDA WARNING_LETTER - Tomita Pharmaceutical Co., Ltd - August 02, 2007

The FDA issued a Warning Letter to Tomita Pharmaceutical Co., Ltd. following a July 31-August 2, 2007, inspection of their Tokushima, Japan, facility, which revealed significant Current Good Manufacturing Practice (CGMP) deviations in Active Pharmaceutical Ingredient (API) manufacturing, rendering their APIs adulterated. The firm also failed to provide requested documents during the inspection and did not submit a written response to the FDA-483 observations.

Key violations include: 1. **Deficient Laboratory Worksheets:** Lack of references to analytical methods, instruments, manufacturer's standards/lot numbers, and proper weight reporting. This was a repeat deviation from a 2005 inspection. 2. **Inadequate Out-of-Specification (OOS) Investigations:** Failure to thoroughly investigate OOS results beyond the laboratory to determine root causes and implement corrective/preventive actions, despite confirming at least seven OOS results. 3. **Unvalidated and Insecure Computerized System:** The analytical instrument lacked password control for users, and data could be deleted, altered, or transferred without a secure audit trail.

These CGMP deviations are not exhaustive. The FDA emphasized the firm's responsibility to comply with all U.S. CGMP standards for continued product shipment to the U.S. The refusal to provide documents was deemed a refusal to allow inspection, potentially leading to import refusal under Section 801(a)(3) of