Excelvision - Fareva

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

You failed to adequately investigate customer complaints for the various sterile **(b)(4)** drug products (prescription and over-the-counter) you manufacture. Your investigations were not thorough, did not appropriately expand in scope, and lacked a scientifically supported determination of root causes. You also failed to identify and implement adequate and timely corrective actions and preventive actions (CAPAs).

Passage 3

You failed to adequately determine which hazards in your manufacturing operation and container-closure systems led to these critical, repeated incidents of contamination in your **(b)(4)** drug products.

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)).

Passage 5

Your firm failed to maintain floors, walls, and ceilings of smooth, hard surfaces that are easily cleanable in aseptic processing areas and establish an adequate system for maintaining equipment used to control the aseptic conditions (21 CFR 211.42(c)(10)(i) and 211.42(c)(10)(vi)).

Passage 6

Your firm failed to establish an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions (21 CFR 211.42(c)(10)(v)).