Exactech, Inc. dba Advita Ortho

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 establish and maintain process control procedures that describe any process controls necessary to ensure conformance to specifications when deviations from device specifications could occur as a result of the manufacturing process, as required by 21 CFR 820.70(a). For example, your firm failed to adequately establish production and process control procedures to ensure that devices conform to specifications.

Passage 2

Failure to adequately establish and maintain procedures for corrective and preventative action, as required by 21 CFR 820.100(a). For example:

Passage 3

Failure to adequately establish and maintain procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90(a). For example, your firm failed to identify, document, evaluate nonconforming product including the need for investigation and notification of the persons or organizations responsible.

Passage 4

Failure of product’s dimensional specifications (**(b)(4)** failure, **(b)(4)** failure, **(b)(4)** failure, **(b)(4)** radius) that may correlate with high scrap rates for dimensional defects.

Passage 5

Failure to adequately establish and maintain procedures to ensure that environmental conditions do not adversely affect product quality, as required by 21 CFR 820.70(c). For example, your firm failed to adequately establish procedures to ensure your environmental controls are being maintained as specified and that your environmental control systems are adequate and functional.

Passage 6

Failure to adequately establish procedures for identifying training needs and ensuring that all personnel are trained to adequately perform their assigned responsibilities, as required by 21 CFR 820.25(b). For example, your firm failed to capture the training of employees as described in the Competency and Training Procedure, 701-103-087, Rev. AB, dated 7/9/2024. FDA inspection noted that:

Passage 7

Failure to adequately establish procedures for acceptance activities, as required by 21 CFR 820.80(a). For example: