Acrostak Schweiz AG

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 maintain procedures for monitoring and control of process parameters for validated processes to ensure that the specified requirements continue to be met as required by 21 CFR 820.75(b)(2) – Process Validation. More specifically, the environmental control validation activities should be monitored and controlled per the established procedures to ensure that specific requirements continue to be met.

Passage 2

Failure to establish and maintain design validation procedures to ensure that devices conform to defined user needs and intended uses; to ensure proper risk analysis is completed; and to ensure the results of the design validation, including identification of the design, method(s), the date, and the individual(s) performing the validation are documented in the design history file, as required by 21 CFR 820.30(g).

Passage 3

Failure to establish and maintain procedures that define the responsibility for rework, to include retesting and reevaluation of the nonconforming product after rework, to ensure that the product meets its current approved specifications per 21 CFR 820.90 (b)(2). For example, your firm manufacturing work instruction for M-CATH microcatheters (WI 158-1, Rev. F; approved 28 September 2022) **(b)(4)**.