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FDA establishment 3002840477, Tainan City, Taiwan. Part of Scinopharm Taiwan's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 8
Official action indicated: 1
Last inspection ended: Jun 23, 2026
Warning letters: 0
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 211.160(b). Scientifically sound laboratory controls Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that 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 and sterilization process.
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 211.25(a). Training , Education , Experience overall Employees engaged in the processing of a drug product lack the training required to perform their assigned functions.
21 CFR 211.113(b). Procedures for sterile drug products Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.
21 CFR 211.68(b). input/output verification Input to and output from the computer are not checked for accuracy.
21 CFR 211.42(b). Product flow through building is inadequate The flow of components, drug product containers, closures, in-process materials and drug products through the building is not designed to prevent contamination.
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
Tainan City, Taiwan. Part of