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# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-133/
- Published: 2017-10-03T12:00:00.000Z
- Updated: 2026-09-14T22:53:47.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5139772

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

**Dasan E&T Co.** Gimpo, Kyonggi-do, Republic of Korea (9/22): FDA inspected the firm in January and cited significant GMPs for finished pharmaceuticals. For example, the firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug products. 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. [https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm577650.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm577650.htm?ref=fdaweb.com)

**Diasol East** San Fernando, CA (7/12): FDA inspected the firm in March and cited GMP deficiencies with its device manufacturing (powder dialysate concentrate for hemodialysis). For example, the firm failed to develop, conduct, control, and monitor production processes to ensure that the device conforms to its specifications. The firm also failed to establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm577520.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm577520.htm?ref=fdaweb.com)