Turkuaz Sağlik Hizmetleri Medikal Temizlik Kimyasa

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 adequately establish and maintain procedures for validating the device design including documenting the results of the design validation in the design history file (DHF), as required by 21 CFR 820.30(g). For example, your firm conducted both microbiological aging stability and challenge validations for your firm’s sterile and non-sterile ultrasound gel products. However, your firm has no data to support the following validation testing:

Passage 2

Failure to have personnel with the necessary education, background, training, and experience to assure that all activities required by this part are correctly performed, as required by 21 CFR 820.25(a). For example, throughout the inspection, your firm was not familiar with the USFDA regulations and requirements for medical device manufacturers exporting medical devices intended for the US market, to include:

Passage 3

Failure to adequately maintain device history records (DHRs), as required by 21 CFR 820.184. For example, your device history records for the Konix sterile ultrasound gel and non-sterile ultrasound gel do not contain the primary identification label and labeling used for production units.