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# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-193/
- Published: 2019-04-16T12:00:00.000Z
- Updated: 2026-09-15T01:20:32.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5143880

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

**Luen Fook Medicine** Johor, Malaysia (4/4): FDA inspected the facility 12/2018 and cited significant GMP violations for finished pharmaceuticals. For example, the company failed to have, for each batch of drug product, an appropriate laboratory determination of satisfactory conformance to final specifications for its drug product. Additionally, the firm failed to establish written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm635686.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm635686.htm?ref=fdaweb.com)

**RIJ Pharmaceutical** Middletown, NY (3/28): FDA inspected the facility 4/2018 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess. The company 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. Additionally, it 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/ucm635684.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm635684.htm?ref=fdaweb.com)

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