Medline Inc

Selected passages from the FDA letter

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

Passage 1

Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).

Passage 2

Your firm failed to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups; failed to perform operations within specifically defined areas of adequate size; and failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.42(c) and 21 CFR 211.67(b)).

Passage 3

You failed to establish appropriate design and control of your manufacturing operation to assure your **(b)(4)** drug products **(b)(4)** were suitable for their intended use. This issue was cited on the previous Form FDA 483 issued to your firm in January 2025 and subsequently discussed during the most recent regulatory meeting conducted with your firm in May 2025.

Passage 4

Failure to address violations may also cause FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any violations.