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# CGMP, Unapproved New Drug Violations at Tender
- URL: https://www.fdaweb.com/cgmp-unapproved-new-drug-violations-at-tender/
- Published: 2020-07-28T12:00:00.000Z
- Updated: 2026-09-14T16:22:47.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147294

An 11/12-11/25/19 FDA inspection at Tender Corp., Littleton, NH, found significant violations of current good manufacturing practice (CGMP) regulations in the firm’s production of over-the-counter unapproved and misbranded new drugs. A 7/23 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tender-corporation-599789-07232020?ref=fdaweb.com) says specific violations were: 

- failing to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards;
- failing to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug productcontainers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity; and
- failing to establish and follow adequate written procedures describing the handling of all written and oral complaints regarding a drug product, including provisions for review by the quality control unit of any complaint involving the possible failure of a drug product to meet any of its specifications and, for such drug products, a determination as to the need for an investigation.

FDA strongly recommends that Tender engage a qualified consultant to assist it in meeting CGMP requirements. The letter says the firm’s quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drug Tender manufactures. It also notes that similar CGMP observations were made in 2016 and 2018 inspections and the firm proposed specific remediations for those observations. “Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate,” FDA says.

The letter also details unapproved new drug and misbranding violations for several of the firm’s over-the-counter products.

Tender was told to promptly correct the violations and prevent their recurrence and to respond with a list of specific steps taken since the inspection to correct the violations and prevent their recurrence, with a timetable for completing the steps.