> ## 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 Violations at Green Wave Analytical
- URL: https://www.fdaweb.com/cgmp-violations-at-green-wave-analytical/
- Published: 2022-08-30T12:00:00.000Z
- Updated: 2026-09-14T17:57:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152618

A 2/15-3/7 FDA inspection at the Green Wave Analytical drug contract testing laboratory in San Diego, CA, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. An 8/19 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/green-wave-analytical-llc-630965-08192022?ref=fdaweb.com) says specific violations were:

- failing to establish and document the accuracy, sensitivity, specificity, and reproducibility of test methods;
- failing to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards;
- failing to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records or other records;
- failing to establish a system for monitoring environmental conditions in aseptic processing areas; and
- failing to establish an adequate quality unit and failing to have the responsibilities and procedures applicable to the quality control unit in writing and fully followed.

The letter reminds Green Wave of its responsibilities as a contract lab and recommends steps for data integrity remediation.

FDA says that during the first three days of the inspection Green Wave denied access to the registered suite for the company and falsely represented that the firm did not perform CGMP testing of finished drug products or components under contract. Because the firm delayed the inspection, its products are adulterated, FDA says.

The agency acknowledges the firm’s commitment during the inspection to de-register and cease CGMP testing of drugs at the facility. It says that if Green Wave intends to resume any activity regulated under the Federal Food, Drug, and Cosmetic Act, it must first notify FDA.

The letter notes that the agency has not received a company response to the inspection observations listed on an FDA-483.

Green Wave was told to respond with a list of specific actions it has taken to respond to the violations, with a schedule for completing the corrections.