Findings citing 21 CFR 211.80

Your firm failed to establish and follow written procedures describing in sufficient detail the receipt, identification, storage, handling, sampling, testing, and approval or rejection of components and drug product containers and closures (21 CFR 211.80(a)). Your firm approved “ (b)(4) ” for use as a component in your drug products. For example, “ (b)(4) ” is approximately (b)(4) % of your (b)(4) drug product. At a minimum, you must use (b)(4) (refer to USP (b)(4) ) to…

(Material System) |1 | I There was a failure to handle and store components at all times in a manner to prevent contamination.

Failure to establish and follow written procedures describing in sufficient detail the receipt, identification, storage, handling, sampling, testing, approval or rejection of components and drug product containers and closures [21 CFR 211.80(a)]. Specifically, your firm lacks written procedures describing in sufficient detail the criteria for approval or rejection of incoming human umbilical cord tissue, amniotic membrane, other components, and drug product containers and closures.

Failure to establish and follow written procedures describing in sufficient detail the receipt, identification, storage, handling, sampling, testing, and approval or rejection of components and drug product containers and closures [21 CFR 211.80(a)]. For example: a. There are no written procedures describing in sufficient detail the criteria for approval or rejection of incoming human umbilical cord blood or human umbilical cord. b. There are no written procedures describing in sufficient detail the acceptance criteria for components used in manufacturing, including (b)(4) micron and (b)(4) micron filters, (b)(4) (glass) bottles, and (b)(4) , and drug product containers and closures.