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FDA establishment 3013559620, Fort Worth, Texas, United States. Part of Eosera's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 3
Official action indicated: 3
Last inspection ended: Mar 20, 2026
Warning letters: 0
Inspections by Fiscal Year
FY2018 to FY2027 to date; 3 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 211.84(e). Rejecting When Specifications Not Met Failure to reject any lot of drug product containers that did not meet the appropriate written specifications for identity, strength, quality, and purity.
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 211.67(b). Written procedures not established/followed Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
21 CFR 211.182. Specific information required in individual logs Individual equipment logs do not show time, date, product and lot number of each batch processed.
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 211.68(a). Calibration/Inspection/Checking not done Routine calibration of automatic and electronic equipment is not performed according to a written program designed to assure proper performance.
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 211.63. Equipment Design, Size and Location Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
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.
21 CFR 211.160(b). Scientifically sound laboratory controls Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
Official Action Indicated (OAI)
Mar 1, 2022
Drugs · Drug Quality Assurance
None posted
Official Action Indicated (OAI)
Jan 17, 2020
Drugs · Drug Quality Assurance
5 cited references
21 CFR 211.84(d)(6). Objectionable microbiological contamination Each lot of a liable to objectionable microbiological contamination is deficiently subjected to microbiological tests before use.
21 CFR 211.165(f). Failing drug products not rejected Drug products failing to meet established specifications are not rejected.
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 211.84(e). Rejecting When Specifications Not Met Failure to reject any lot of components that did not meet the appropriate written specifications for identity, strength, quality, and purity.
21 CFR 211.110(a). Control procedures to monitor and validate performance Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
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
Fort Worth, Texas, United States. Part of