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# CGMP Violations Found in Seatex Inspection
- URL: https://www.fdaweb.com/cgmp-violations-found-in-seatex-inspection/
- Published: 2024-05-21T12:00:00.000Z
- Updated: 2026-09-14T14:31:24.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157024

An FDA 10/16-10/20/2023 inspection at the Seatex drug manufacturing facility in Rosenberg, TX, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 4/1 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/seatex-llc-672951-04012024-0?ref=fdaweb.com) says specific violations were:

- failure to establish and follow adequate written procedures for cleaning and maintenance of equipment;
- failure 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;
- failure to conduct at least one test to verify the identity of each component of a drug product and failure to validate and establish the reliability of a component supplier’s test analyses at appropriate intervals; and
- failure of the firm’s quality control unit to exercise its responsibility to ensure drug products manufactured comply with CGMP and meet established specifications for identity, strength, quality, and purity.

FDA acknowledges the firm’s commitment to cease production of all drugs at the facility. Seatex was told to correct all violations promptly and to respond with a list of specific actions it has taken or will take to address the violations and prevent their recurrence, with a schedule for completing the corrections.