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FDA establishment 1000132299, Baton Rouge, Louisiana, United States. Part of Owen Biosciences's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 7
Official action indicated: 3
Last inspection ended: May 15, 2026
Warning letters: 1
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 211.192. No written record of investigation Written records are not made of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications.
21 CFR 211.113(a). Procedures for non-sterile drug products Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established.
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.
Official Action Indicated (OAI)
Mar 27, 2025
Drugs · Drug Quality Assurance
6 cited references
21 CFR 211.137(a). Expiration date lacking Drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.
21 CFR 211.194(e). Stability testing records not included Laboratory records do not include complete records of all stability testing performed.
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 211.25(a). GMP Training Frequency GMP training is not conducted on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.
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.
21 CFR 211.166(a)(4). Testing in same container - closure system The written stability program does not assure testing of the drug product in the same container-closure system as that in which the drug product is marketed.
Official Action Indicated (OAI)
Feb 14, 2020
Drugs · Drug Quality Assurance
9 cited references
21 CFR 211.188(b). Batch production and Batch Control Record Requirements The batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in manufacturing and processing.
21 CFR 211.105(a). Identification of containers, lines, equipment All compounding and storage containers, processing lines and major equipment used during the production of a batch of drug product is not properly identified at all times to indicate contents and the phase of processing of the batch.
21 CFR 211.142. Written warehousing procedures established/followed Procedures describing the warehousing of drug products are not followed.
21 CFR 211.188(a). Accurate reproduction The batch production and control records are deficient in that they are not an accurate reproduction of the appropriate master production or control record.
21 CFR 211.25(a). Training , Education , Experience overall Employees engaged in the manufacture and processing of a drug product lack the training required to perform their assigned functions.
21 CFR 211.186(b)(9). Complete instructions, procedures, specifications et. al. Master production and control records lack specifications.
21 CFR 211.68(a). Calibration/Inspection/Checking not done Routine calibration, inspection and checking of mechanical equipment is not performed according to a written program designed to assure proper performance.
21 CFR 211.101(c). Weighing/measuring/subdividing supervision Component weighing, measuring and subdividing operations are not adequately supervised.
21 CFR 211.25(b). Supervisor Training/Education/Experience Individuals responsible for supervising the manufacture and processing of a drug product lack the training to perform their assigned functions in such a manner as to assure the drug product has the safety, identity, strength, quality and purity that it purports or is represented to possess.
Voluntary Action Indicated (VAI)
Sep 14, 2016
Drugs · Drug Quality Assurance
4 cited references
21 CFR 211.192. No written record of investigation Written records are not always made of investigations into unexplained discrepancies.
21 CFR 211.166(b). Accelerated stability studies Accelerated stability studies, combined with basic stability information, used to support tentative expiration dates are not supported with ongoing full shelf life studies.
21 CFR 211.68(a). Calibration/Inspection/Checking not done Routine inspection and checking of automatic, mechanical and electronic equipment is not performed according to a written program designed to assure proper performance.
21 CFR 211.160(b)(4). Test devices not meeting specifications Test devices are deficient in that instruments not meeting established specifications are used.
Voluntary Action Indicated (VAI)
Jun 24, 2013
Drugs · Drug Quality Assurance
5 cited references
21 CFR 211.180(e)(2). Items to cover on annual reviews Written procedures are not followed for evaluations done at least annually and including provisions for a review of complaints, recalls, returned or salvaged drug products, and investigations conducted for each drug product.
21 CFR 211.165(a). Testing and release for distribution Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications prior to release.
21 CFR 211.68(a). Calibration/Inspection/Checking not done Routine calibration and checking of equipment is not performed according to a written program designed to assure proper performance.
21 CFR 211.192. Written record of investigation incomplete Written records of investigations into unexplained discrepancies do not include the conclusions and follow-up.
21 CFR 211.166(b). Accelerated stability studies Accelerated stability studies, combined with basic stability information, used to support tentative expiration dates are not supported with ongoing full shelf life studies.
Voluntary Action Indicated (VAI)
Aug 19, 2011
Drugs · Drug Quality Assurance
10 cited references
21 CFR 211.160(b). Scientifically sound laboratory controls Laboratory controls do not include the establishment of scientifically sound and appropriate designed to assure that components and drug product containers conform to appropriate standards of identity, strength, quality and purity.
21 CFR 211.192. Quality control unit review of records Drug product production and control records, are not reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed.
21 CFR 211.166(b). Adequate number of batches on stability An adequate number of batches of each drug product are not tested to determine an appropriate expiration date.
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 211.180(e)(1). Review of representative number of batches Written procedures are not established and followed for evaluations conducted at least annually to review records associated with a representative number of batches, whether approved or rejected.
21 CFR 211.84(d)(2). Reports of Analysis (Components) Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without performing at least one specific identity test on each component and establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.
21 CFR 211.182. Written records kept in individual logs Written records of major equipment maintenance and use are not included in individual equipment logs.
21 CFR 211.110(a). Control procedures fail to include the following Control procedures fail to include adequacy of mixing to assure uniformity and homogeneity.
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 211.188(b)(8). Labeling control records including specimens or copies Batch production and control records do not include complete labeling control records, including specimens or copies of all labeling used for each batch of drug product produced.
Official Action Indicated (OAI)
Sep 23, 2009
Drugs · Drug Quality Assurance
None posted
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. 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
Baton Rouge, Louisiana, United States. Part of