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# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-134/
- Published: 2017-10-10T12:00:00.000Z
- Updated: 2026-09-14T22:55:09.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5139832

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

**Diasol Inc.** San Fernando, CA (9/28): FDA inspected the firm in June and cited GMP deficiencies with Dryasol liquid acid concentrates, Dryasol powder mixes, CitriSol concentrate, liquid Diasol acid concentrates, and liquid and powder sodium bicarbonate. For example, the firm 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. The firm also failed to establish and maintain procedures to control product that does not conform to specified requirements.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm579094.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm579094.htm?ref=fdaweb.com)

**Euro Diagnostica AB** Skane, Sweden (9/20): FDA inspected the firm in January and cited GMP deficiencies with *in vitro* diagnostic devices, including the Euro-Diagnostica CCPoint. For example, the firm failed to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit. It also failed to document all corrective and preventive action activities and their results.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm578374.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm578374.htm?ref=fdaweb.com)

**Option Care Enterprises**, Bannockburn, IL (9/28): FDA inspected the firm 9/2016 and cited serious deficiencies in its practices for producing sterile drug products. FDA investigators observed that operators demonstrated poor aseptic practices, such as moving rapidly within the ISO 5 area. In addition, the firm did not completely disinfect components and materials at each transition from areas of lower quality air to areas of higher quality (e.g., ISO 7 cleanroom to ISO 5 hood).  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm578543.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm578543.htm?ref=fdaweb.com)

**Laveeza Bhatti** Beverly Hills, CA (8/4): FDA inspected the clinical investigator’s site in 2016 and concluded that the individual did not adhere to the applicable statutory requirements and FDA regulations governing the conduct of clinical investigations and the protection of human subjects. For example, the clinical investigator failed to ensure that the investigation was conducted according to the investigational plan. The individual also failed to retain records required to be maintained for two years.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm578987.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm578987.htm?ref=fdaweb.com)