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# Calvin Scott & Company CGMP Violations
- URL: https://www.fdaweb.com/calvin-scott-company-cgmp-violations/
- Published: 2020-09-08T12:00:00.000Z
- Updated: 2026-09-14T16:28:01.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147596

A 3/9-3/12 FDA inspection at the Calvin Scott and Company drug manufacturing facility in Albuquerque, NM, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. An 8/25 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/calvin-scott-company-inc-606987-08252020?ref=fdaweb.com) says specific violations were: 

- failing to assure that the drug product bore an expiration date that was supported by appropriate stability testing;
- failing to establish and follow adequate written procedures for cleaning and maintenance of equipment; and
- failing to establish a quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products.

FDA says that, based on the nature of the violations, it strongly recommends that the firm engage a qualified consultant to assist it in meeting CGMP requirements.

The company was told to respond with a list of specific actions taken since the inspection to correct the violations and prevent their recurrence, with a schedule for completing the actions.