> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# CGMP Issues at Compounder’s International
- URL: https://www.fdaweb.com/cgmp-issues-at-compounders-international/
- Published: 2025-09-02T12:00:00.000Z
- Updated: 2026-09-14T15:20:43.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159790

A 2/24-3/5 FDA inspection at Chromatography Institute of America, doing business as Compounder’s International Analytical Laboratory in Castle Rock, CO, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs and significant deviations from CGMP for active pharmaceutical ingredients. An 8/20 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/chromatography-institute-america-dba-compounders-international-analytical-laboratory-708944-08202025?ref=fdaweb.com) says the specific violations were a lack of adequate:

- laboratory control mechanisms;
- investigations; and
- Quality Unit oversight.

The letter says the firm’s responses to the inspection observations were inadequate.

FDA acknowledges the company indicated it was going to close its contract testing laboratory, but says several statements in its responses to the form FDA-483 conflict with that declaration. The agency asks for clarification of the lab’s operational status and says remediation of the violations and deviations will be necessary if the current company, a successor, or an acquirer resumes drug testing operations at the site.

FDA says that if the firm intends to resume testing drugs, it should engage a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements.

Compounder’s International was told to address the violations promptly and to respond with a list of specific actions it has taken to correct the violations and prevent their recurrence, with a schedule for completing the corrections.