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FDA establishment 3004396086, Tai Nan Shi, Taiwan. Part of Nang Kuang Pharmaceutical's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 5
Official action indicated: 1
Last inspection ended: Apr 2, 2024
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 211.68(b). Computer control of master formula records Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
21 CFR 211.94(a). Reactive/Additive/Absorptive Containers/Closures Drug product containers or closures are additive so as to alter the safety, identity, strength, quality, and purity of the drug beyond the official or established requirements.
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 components, drug product containers, closures, in-process materials and drug products conform to appropriate standards of identity, strength, quality and purity.
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 211.194(a)(4). Complete Test Data Laboratory records are deficient in that they do not include a complete record of all data obtained during testing.
21 CFR 211.42(c)(10)(iv). Environmental Monitoring System Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
Official Action Indicated (OAI)
Nov 6, 2018
Drugs · Drug Quality Assurance
None posted
Voluntary Action Indicated (VAI)
Sep 5, 2017
Drugs · Drug Quality Assurance
6 cited references
21 CFR 211.25(a). Training , Education , Experience overall Employees engaged in the manufacture, processing and packing of a drug product lack the required to perform their assigned functions.
21 CFR 211.194(a)(4). Complete Test Data Laboratory records are deficient in that they do not include a complete record of all data obtained during testing. 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 211.84(d)(2). Testing Each Component for Conformity with Specs Each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality. Electronic records are used, but they do not meet audit trail requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records.
21 CFR 211.42(c)(10)(iv). Environmental Monitoring System Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
21 CFR 211.113(b). Validation lacking for sterile drug products Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of the sterilization process.
21 CFR 211.165(e). Test methods The accuracy, sensitivity, specificity and reproducibility of test methods have not been established and documented.
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
Tai Nan Shi, Taiwan. Part of