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# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-210/
- Published: 2019-09-17T12:00:00.000Z
- Updated: 2026-09-15T01:50:20.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5145025

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

**Deb USA**, Dallas, TX (6/11): FDA inspected the firm 10/2018 and cited significant GMP violations for finished pharmaceuticals. For example, the company failed to establish adequate written responsibilities and procedures applicable to the quality control unit and to follow such written procedures. It also failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity. And laboratory personnel failed to follow written procedures for testing components and drug products. To view the letter, click [here](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/deb-usa-inc-570944-06112019?ref=fdaweb.com).

**21st Century Scientific**, Coeur d’Alene, ID (5/13): FDA inspected the firm 9/2018 and determined that its Bounder powered wheelchairs are misbranded because modifications to the devices were not cleared by the agency. FDA also said the company’s FDA-483 response did not provide descriptions of its design validation and verification activities that support a conclusion that modifications do not add additional risk based on a risk analysis. The letter determined that the modifications were significant and require a new 510(k) submission. To view the letter, click [here](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/21st-century-scientific-inc-566834-05132019?ref=fdaweb.com).