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# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-136/
- Published: 2017-10-24T12:00:00.000Z
- Updated: 2026-09-14T22:57:49.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5139951

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

**DRG Instruments GmbH** Marburg, Germany (9/19): FDA inspected the firm 10/2016 and cited significant GMP deviations with the 17-alpha-OH Progesterone ELISA, Salivary Cortisol ELISA, Estradiol ELISA, Salivary Testosterone ELISA and Testosterone ELISA devices. For example, the firm failed to establish and maintain process control procedures that describe any process controls necessary to ensure conformance to specifications where deviations from device specifications could occur as a result of the manufacturing process. It also failed to identify the actions needed to correct and prevent recurrence of nonconforming product and other quality problems.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm580968.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm580968.htm?ref=fdaweb.com)

**ELITech Group SAS** Puteaux, France (9/20): FDA inspected the firm in March and cited GMP violations with Selectra Pro S, Selectra Pro M and Viva Junior Analyzer devices. For example, the firm failed to adequately establish and maintain procedures for corrective and preventive action activities (CAPA) and failure to adequately document CAPA results. It also failed to adequately establish and maintain procedures for receiving, reviewing, and evaluating complaints.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm581033.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm581033.htm?ref=fdaweb.com)

**Pelvic Therapies** Carlsbad, CA (10/17): FDA has determined that the firm distributes and promotes the Essential TheraWand, Premium TheraWand, PelviWand-LA and PelviWand-V products in the U.S. without marketing clearance or approval. The agency says the products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or any function of the body.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm580966.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm580966.htm?ref=fdaweb.com)

**Sohail M. Khan** Lynn Haven, FL (10/10): FDA inspected the clinical investigator’s clinical site in July and determined that the investigator did not adhere to the applicable statutory requirements and FDA regulations governing the conduct of clinical investigations. For example, the clinical investigator failed to retain records required to be maintained for a period of two years following the date a drug marketing application is approved.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm580682.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm580682.htm?ref=fdaweb.com)

**UVLrx Therapeutics** Oldsmar, FL (9/25): FDA inspected the firm in March to verify sponsor obligations related to the clinical study “UVL\_0001 A Polychromatic Light Emitting Diode System to Deliver Low Dose Light Directly into a Peripheral Intravascular Catheter: A Safety and Feasibility Study.” The inspection cited the firm for failing to obtain Institutional Review Board approval for studies conducted. The firm was also cited the firm for failing to comply with sponsor monitoring requirements.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm580994.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm580994.htm?ref=fdaweb.com)

**Vital Laboratories** Gujarat, India (10/10): FDA inspected the firm in April and found significant GMP deviations with its active pharmaceutical ingredients (API) manufacturing. For example, the firm failed to ensure all production deviations are reported and evaluated, and that critical deviations are investigated and the conclusions are recorded. The firm also failed to adequately document the completion of each significant step in the batch production records with signatures of the persons performing and directly supervising or checking each critical step in the operation.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm580751.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm580751.htm?ref=fdaweb.com)