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FDA Warning Letter Explorer
FDA warning letter · Drugs

Bioiberica, SAU

Issued · Posted by FDA

FDA published a close-out letter on Jan 29, 2025. The passages below are from the original warning letter.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Failure to establish written procedures to monitor the progress and control the performance of processing steps that may cause variability in the quality characteristics of your intermediates and API.

Passage 2

Failure to ensure that reworked batches have been subjected to appropriate evaluation and stability testing to show that the reworked material is of equivalent quality to that produced by the original process.