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# CGMP Issues at Japan’s Sato Pharmaceutical Co.
- URL: https://www.fdaweb.com/cgmp-issues-at-japans-sato-pharmaceutical-co/
- Published: 2026-05-26T12:00:00.000Z
- Updated: 2026-09-14T13:39:54.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161196

An 11/13-11/21/2025 FDA inspection at the Sato Pharmaceutical drug manufacturing facility in Tokyo, Japan, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 5/18 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sato-pharmaceutical-co-ltd-723059-05182026?ref=fdaweb.com) says the specific violations were:

- failure to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, including validation of all aseptic processes;
- failure to conduct, for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms, and failure to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates; and
- failure to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that redacted over-the-counter drug products conform to appropriate standards of identity, strength, quality, and purity.

The letter acknowledges that Sato halted production for the United States until corrective actions are made and successful media fills are completed. FDA recommended that the company engage a qualified consultant to evaluate its operations through a comprehensive six-system audit and assist it in meeting CGMP requirements.

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