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# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-129/
- Published: 2017-09-05T12:00:00.000Z
- Updated: 2026-09-14T22:46:48.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139548

FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.

**MB Industria Cirurgica** Paulista, Brazil (8/4): FDA inspected the firm’s wound dressing manufacturing facility in March and cited significant GMP violations. For example, the firm failed to ensure that when the results of a process cannot be fully verified by subsequent inspection and test that the process shall be validated. It was also cited for failing to adequately control environmental conditions.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm574275.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm574275.htm?ref=fdaweb.com)

**QLRAD Netherlands** Overijssel, Netherlands (7/20): FDA notified the firm that it is marketing the RectalPro Endorectal Balloon (ERB) in the United States without marketing clearance or approval. It told the firm that a de novo request had been approved to classify similar prostate immobilization devices into Class 2\. The letter recommends submitting a 510(k) that references the de novo classification in order to legally market the device.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm574153.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm574153.htm?ref=fdaweb.com)

**Steiner Biotechnology** Henderson, NV (6/21): FDA inspected the firm 12/2016 and cited objectionable conditions related to activities and procedures as a sponsor-investigator in significant risk clinical studies of Ridge Graft and Skeletal Graft. For example, the firm failed to submit an IDE application to FDA. Additionally, the firm failed to maintain accurate, complete, and current records relating to its participation in an investigation.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm574159.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm574159.htm?ref=fdaweb.com)

**SyncThink, Inc.** Boston, MA (7/31): FDA objected to the firm’s marketing of its Eye-Sync device for cognitive assessment/testing of concussions and head trauma, including in injured athletes and soldiers**,** which would constitute a major change or modification to its intended use. The device was originally cleared as a prescription device for recording, viewing, and analyzing eye movements in support of identifying visual tracking impairment in human subjects.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm574155.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm574155.htm?ref=fdaweb.com)