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FDA establishment 3004886113, Yongin, Korea (the Republic of). Part of Hanlim Pharm Co., Ltd.'s FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 6
Official action indicated: 2
Last inspection ended: Apr 24, 2026
Warning letters: 3
Import refusals 2014 to 2023: 2, first Jun 13, 2018
Inspections by Fiscal Year
FY2018 to FY2027 to date; 2 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 211.166(a). Results not used for expiration dates, storage cond. Results of stability testing are not used in determining expiration dates.
21 CFR 211.100(a). Absence of Written Procedures Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
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 211.42(c). Defined areas of adequate size for operations The separate or defined areas and control systems necessary to prevent contamination or mix-ups are deficient.
21 CFR 211.22(d). Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not fully followed.
21 CFR 211.67(a). Cleaning / Sanitizing / Maintenance Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
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 did not include adequate validation of the aseptic process.
21 CFR 211.160(a). Following/documenting laboratory controls Established test procedures are not documented at the time of performance.
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 211.42(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.
Official Action Indicated (OAI)
Apr 10, 2026
Drugs · Bioresearch Monitoring
None posted
No Action Indicated (NAI)
May 31, 2022
Drugs · Drug Quality Assurance
2 cited references
21 CFR 211.68(b). input/output verification Input to and output from the computer and records or data are not checked for accuracy.
21 CFR 211.68(b). Backup file not maintained Failure to maintain a backup file of data entered into the computer or related system. 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.
Voluntary Action Indicated (VAI)
Feb 6, 2018
Drugs · Drug Quality Assurance
7 cited references
21 CFR 211.160(b). Scientifically sound laboratory controls Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
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). 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 211.42(c)(10)(iv). Environmental Monitoring System Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
21 CFR 211.160(a). Following/documenting laboratory controls Established test procedures are not documented at the time of performance.
21 CFR 211.68(b). Backup data not assured as exact and complete Backup data is not assured as secure from alteration, erasure or loss through keeping hard copy or alternate systems.
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 followed.
Official Action Indicated (OAI)
Jul 19, 2016
Drugs · Drug Quality Assurance
None posted
Voluntary Action Indicated (VAI)
Apr 18, 2014
Drugs · Drug Quality Assurance
5 cited references
21 CFR 211.25(a). GMP Training Frequency GMP training is not conducted with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.
21 CFR 211.186(b)(3). Component Name and Code The master production and control records are deficient in that they do not include a complete list of components designated by name and code sufficiently specific to indicate any special characteristic.
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 211.67(c). Cleaning/maintenance records not kept Records are not kept for the maintenance, cleaning, sanitizing, and inspection of equipment.
21 CFR 211.42(c)(10). Aseptic Processing Area Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic processing of drug products.
Voluntary Action Indicated (VAI)
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. Recalls come from FDA's enforcement reports (iRES), one row per recall even when it covers many lots. 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, warning letters and enforcement reports
Yongin, Korea (the Republic of). Part of