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# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-189/
- Published: 2019-03-19T12:00:00.000Z
- Updated: 2026-09-15T01:13:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143649

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

**Integra LifeSciences** Plainsboro, NJ (3/6): FDA inspected Integra’s TEI Biosciences facility in Boston 10/2018 and cited GMP violations for its collagen based medical devices. For example, the firm failed to validate a certain process used in making extracellular bovine matrix medical devices, including Xenform Soft Tissue Repair Matrices. TEI also failed to establish and maintain procedures to prevent contamination of equipment or product by substances that could reasonably be expected to have an adverse effect on product quality. Additionally, the company had not used a sporicidal disinfectant in its ISO 7 clean rooms since 3/2017.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm633145.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm633145.htm?ref=fdaweb.com)

**Mentor Worldwide and Acclarent Irvine**, CA (3/18): Company is in violation of post-approval study requirements for its MemoryShape Breast Implants. Specifically, Mentor failed to evaluate the long-term clinical performance of MemoryShape Breast Implants under general conditions of use in the postmarket environment, and it failed to enroll 2,518 women receiving MemoryShape Breast Implants and 300 women undergoing other aesthetic surgery as the comparison group.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm633710.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm633710.htm?ref=fdaweb.com)

**Nutra Pharma** Coral Springs, FL (3/11): FDA reviewed marketing and product claims on the company’s [*www.nyloxin.com*](http://www.nyloxin.com/?ref=fdaweb.com) Web site and determined that it is marketing unapproved drugs. Drug claims are wrongly being made for unapproved products for treating addiction and chronic pain, including pain associated with cancer, diabetes, shingles, fibromyalgia and other serious conditions.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm633800.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm633800.htm?ref=fdaweb.com)

**Sientra, Inc.** Santa Barbara, CA (3/18): Company is in violation of post-approval study requirements for its Sientra Silicone Gel Breast Implants. Specifically, Sientra failed to evaluate the long-term clinical performance of Sientra Silicone Gel Breast Implants under general conditions of use in the U.S., and it has failed to follow the study subjects annually for 10 years.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm633719.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm633719.htm?ref=fdaweb.com)

**United Exchange** Cypress, CA (3/6): FDA inspected the firm 4/2018 and cited significant GMP violations for finished pharmaceuticals. For example, the company failed to establish a quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products, including drug products manufactured, processed, packed or held under contract by another company. The inspection also found that United Exchange was not performing final reviews of each batch to determine its disposition.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm633205.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm633205.htm?ref=fdaweb.com)