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# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-143/
- Published: 2017-12-12T12:00:00.000Z
- Updated: 2026-09-14T23:07:14.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140330

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

**Fagron Compounding Services** Wichita, KS (11/28): FDA inspected the outsourcing drug facility in 2016 and cited serious deficiencies in its practices for producing sterile drug products. For example, the firm failed to establish and follow adequate written procedures applicable to the quality control unit. It also did not have appropriate laboratory determinations of satisfactory conformance to final specifications for each drug product.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm587714.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm587714.htm?ref=fdaweb.com)

**RC Outsourcing**, Lowellville, OH (11/28): FDA inspected the drug outsourcing facility in March and noted serious deficiencies in its practices for producing compounded sterile drug products. For example, the firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products. The firm also failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm587833.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm587833.htm?ref=fdaweb.com)

**Seindni Co.** Seoul, Korea (12/5): FDA inspected the firm in May and cited GMP violations for finished pharmaceuticals. For example, the firm failed to establish a quality control unit and procedures to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products. The letter recommended that the firm retain a GMP consultant to correct its violations.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm588215.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm588215.htm?ref=fdaweb.com)