Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
FDA establishment 3004055563, Hachioji, Japan. Part of Sato Pharmaceutical Co., Ltd.'s FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 4
Official action indicated: 2
Last inspection ended: Nov 21, 2025
Warning letters: 2
Inspections by Fiscal Year
FY2018 to FY2027 to date; 1 classified OAI
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
21 CFR 211.192. Investigations of discrepancies, failures There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
21 CFR 211.28(a). Protective Apparel Not Worn Protective apparel is not worn as necessary to protect drug products from contamination.
21 CFR 211.165(e). Test methods The accuracy, sensitivity, specificity and reproducibility of test methods have not been established and documented.
21 CFR 211.67(a). Cleaning / Sanitizing / Maintenance Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drug product.
21 CFR 211.166(a)(3). Valid stability test methods The written stability program for drug products does not include specific test methods.
21 CFR 211.42(c)(10)(v). Cleaning System Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
21 CFR 211.166(a). Written program not followed The written stability testing program is not followed.
21 CFR 211.160(b). Scientifically sound laboratory controls Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling and drug products conform to appropriate standards of identity, strength, quality and purity.
21 CFR 211.113(b). Validation lacking for sterile drug products Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process.
21 CFR 211.22(a). Approve or reject components, products The quality control unit lacks the responsibility and authority to approve and reject all drug products.
Official Action Indicated (OAI)
Oct 25, 2019
Drugs · Drug Quality Assurance
8 cited references
21 CFR 211.68(a). Calibration/Inspection/Checking not done Routine inspection and checking of automatic and electronic equipment is not performed according to a written program designed to assure proper performance. Electronic records are used, but they do not meet requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records.
21 CFR 211.192. Investigations of discrepancies, failures There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
21 CFR 211.58. Buildings not maintained in good state of repair Buildings used in the holding of a drug product are not maintained in a good state of repair.
21 CFR 211.142. Written warehousing procedures established/followed Procedures describing the warehousing of drug products are not established.
21 CFR 211.67(a). Cleaning / Sanitizing / Maintenance Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
21 CFR 211.188(b)(5). In-Process and Laboratory Control Results The batch production and control records are deficient in that they do not include laboratory control results.
21 CFR 211.42(b). Adequate space lacking to prevent mix-ups and contamination The building lacks adequate space for the orderly placement of equipment and materials to prevent mix-ups between different components and drug products and to prevent contamination.
21 CFR 211.160(a). Following/documenting laboratory controls Established standards and laboratory control mechanisms are not followed. Electronic records are used, but they do not meet requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records.
Voluntary Action Indicated (VAI)
Jul 3, 2018
Drugs · Drug Quality Assurance
None posted
Voluntary Action Indicated (VAI)
Feb 12, 2016
Drugs · Drug Quality Assurance
6 cited references
21 CFR 211.194(c). Testing and standardization of standards et. al. Laboratory records do not include complete records of any testing and standardization of laboratory reference standards , reagents and standard solutions .
21 CFR 211.42(c)(10)(iv). Environmental Monitoring System Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
21 CFR 211.194(a)(2). Laboratory Test Method Verification Verification of the suitability of the testing methods is deficient in that they are not performed under actual conditions of use and documented on the laboratory records .
21 CFR 211.42(c)(10)(iii). Air Supply Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure.
21 CFR 211.113(b). Validation lacking for sterile drug products Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include validation of the sterilization process.
21 CFR 211.80(b). Handling and Storage to Prevent Contamination There was a failure to handle and store drug product containers and closures at all times in a manner to prevent contamination.
Official Action Indicated (OAI)
Warning Letters
Letters naming this establishment; each opens the letter
An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm.FDA Data Dashboard and warning letters
Hachioji, Japan. Part of