FDA WARNING_LETTER - Bioiberica, SAU - February 04, 2022

The FDA inspected Bioiberica, SAU, an API manufacturing facility in Palafolls, Barcelona, from January 31 to February 4, 2022, and found significant deviations from current Good Manufacturing Practice (CGMP). Consequently, the firm's API is deemed adulterated under section 501(a)(2)(B) of the FD&C Act. The inspection revealed three primary violations. First, the firm failed to establish written procedures to monitor and control processing steps causing variability, specifically for approximately 23 reworked batches of (b)(4) USP, API due to microbiological OOS or high (b)(4) content, using an unvalidated industrial (b)(4) without proper monitoring. Second, reworked batches were not subjected to appropriate evaluation and stability testing to confirm equivalent quality to material produced by the original process, with no stability data for marketed reworked batches. Third, the firm lacked an adequate ongoing program for monitoring process control to ensure stable manufacturing operations and consistent drug quality. The FDA deemed the firm's response inadequate, noting a mischaracterization of rework as reprocessing and a lack of interim measures. The FDA strongly recommended engaging a CGMP consultant. The firm must promptly correct all deviations, provide a written response within 15 working days detailing corrective actions, and address recurrence prevention. Failure to comply may result in withheld approvals, re-inspection, or refusal of admission of products into the U.S.