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# CGMP Violations at TG United
- URL: https://www.fdaweb.com/cgmp-violations-at-tg-united/
- Published: 2019-08-20T12:00:00.000Z
- Updated: 2026-09-15T01:45:01.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144801

A 12/17/18-2/15/19 FDA inspection at TG United, Brooksville, FL, found current good manufacturing practice (CGMP) violations in the firm’s production of finished pharmaceuticals. An 8/1 [Warning Letter](ttps://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tg-united-inc-577583-08012019) says specific violations 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 use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance;
- failing to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, strength, quality, or purity of the drug product beyond the official or other established requirements; and
- failing to follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates.

The letter notes that FDA cited similar violations in 2010, 2012, 2014, and 2017 inspections and issued a 7/2011 Notice of Violation followed by a 12/2012 regulatory meeting. “Failure to remediate such violations, among many others, cited on the form FDA-483, inspectional observations, demonstrates that executive management oversight and control over the manufacture of drugs is inadequate,” the letter says. “This repeated failure to correct brings into question your firm’s ability to manufacture drugs according to CGMP.”

The agency recommends the firm retain a qualified consultant to assist it in meeting CGMP requirements. It notes that using a consultant does not relieve the company’s executive management of its responsibility to resolve all deficiencies and systemic flaws to ensure ongoing CGMP compliance.

FDA also says that TG manufactures several over-the-counter products that do not comply with the final rule for cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use. And, it says, the agency is not aware of sufficient evidence to show that the products as labeled are generally recognized as safe and effective. Therefore, the letter says, they are considered to be new drugs under the Federal Food, Drug, and Cosmetic Act and are not the subject of FDA-approved applications.

TG 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.