Simtra BioPharma Solutions

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 perform operations within specifically defined areas of adequate size and to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups in aseptic processing areas (21 CFR 211.42(c)(10)).

Passage 2

You failed to sufficiently address the underlying cause of residual **(b)(4)** in a timely manner, instead relying on personnel to **(b)(4)** dry any observed moisture.

Passage 3

You failed to adequately maintain equipment to assure aseptic conditions. Your **(b)(4)** integrity testing program for **(b)(4)** was found to be deficient. For example:

Passage 4

Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)).