Wissner-Bosserhoff GmbH

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 ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing valid results, as required by 21 CFR 820.72(a).

Passage 2

Failure to adequately establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a).

Passage 3

Failure to adequately establish and maintain the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants, as required by 21 CFR 820.50(a).

Passage 4

Your firm did not submit any documents to support your corrective and preventive measures, which were to have been completed from June 21, 2024, to July 31, 2024. Furthermore, the response did not indicate that you would review the qualifications of your suppliers to ensure the products or services provided conform to your specified requirements.

Passage 5

Failure to adequately establish and maintain design output procedures that contain or make reference to acceptance criteria and ensure that those design outputs that are essential for the proper functioning of the device are identified, as required by 21 CFR 820.30(d).

Passage 6

Failure to adequately establish and maintain procedures for acceptance of incoming product, as required by 21 CFR 820.80(b).

Passage 7

Failure to adequately establish and maintain procedures to control all documents that are required by 21 CFR 820, as required by 21 CFR 820.40. For example: The Assembly Instructions, Document V065-01, for the Sentida SC nursing beds failed to include a reference to the drawing technical number and revision level to ensure employees are using the correct drawing when assembling the beds.

Passage 8

Failure to adequately establish and maintain procedures to ensure that device history records (DHR) for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR and the requirements of this part, as required by 21 CFR 820.184.

Passage 9

Failure to keep a record of a correction or removal that contains information including a justification for not reporting the correction or removal action to FDA which shall contain conclusions and any follow-ups, and be reviewed and evaluated by a designated person, as required by 21 CFR Part 806.20(b)(4).