FDA Finds Multiple Violations at Sharplight Technologies

Failing to establish and maintain procedures for verifying the device design.

Failing to establish and maintain procedures for identifying, documenting, validating, or, where appropriate, verifying, reviewing, and approving design changes before their implementation

Failing to establish and maintain procedures for validating device design.

Failing to establish and maintain procedures to ensure formal documented reviews of the design results are planned and conducted at appropriate states of the device’s design development.

Failing to establish and maintain plans that describe or reference the design and development activities and define responsibilities for implementation.

Failing to review, evaluate, and investigate any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications unless such investigation has already been performed for a similar complaint and another investigation is not necessary.

Failing to review and evaluate all complaints to determine whether an investigation is necessary and, when no investigation is made, to maintain a record that includes the reason no investigation was made and the name of the individual responsible for the decision not to investigate.

Failing to establish and maintain procedures for rework, including retesting and reevaluation of the nonconforming product after rework, to ensure that the product meets its current approved specifications.

Failing to establish and maintain procedures to ensure that device history records for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the device master record.

Failing to establish and maintain procedures for changes to a specification, method, process, or procedure.

Failing to establish and maintain procedures to control all documents.