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# Clover Custom Blending CGMP Violations
- URL: https://www.fdaweb.com/clover-custom-blending-cgmp-violations/
- Published: 2018-03-27T12:00:00.000Z
- Updated: 2026-09-14T23:55:32.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141069

A 5/15-5/17/17 FDA inspection at Clover Custom Blending, Tampa, FL, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 2/28 [Warning Letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm602039.htm?ref=fdaweb.com). Specific violations cited in the letter were: 

- failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed;
- failing to establish written responsibilities and procedures applicable to the quality control unit;
- failing to maintain adequate separate defined areas necessary to prevent contamination or mix-up; and
- failing to conduct at least one test to verify the identity of each component of a drug product and failing to establish the reliability of component supplier analyses on which the firm relies in lieu of certain tests through appropriate validation of the supplier’s test results at appropriate intervals.

The letter also says the firm’s Bulk SPF 30 Sunscreen Tote is misbranded. FDA recommends the company engage a qualified third-party consultant to assist it in meeting CGMP requirements. Clover Custom Blending was told to respond with a list of steps taken since the inspection to correct the violations and prevent their recurrence, with a timetable for completion.