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FDA establishment 1020294, Olive Branch, Mississippi, United States. Part of J. Strickland and Co.'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: Nov 20, 2025
Warning letters: 0
Inspections by Fiscal Year
FY2018 to FY2027 to date; 0 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 specifications, sampling plans and test procedures designed to assure that components, in-process materials and drug products conform to appropriate standards of identity, strength, quality and purity.
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.
21 CFR 211.84(d)(1). Component identity verification Drug product component testing is deficient in that at least one specific test to verify the identity of each component is not performed.
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 identity and strength of each active ingredient prior to release.
Voluntary Action Indicated (VAI)
Nov 23, 2021
Drugs · Drug Quality Assurance
2 cited references
21 CFR 211.160(b)(3). Acceptance of drug products Determinations of conformance to appropriate written specifications for acceptance are deficient for drug products.
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.
Voluntary Action Indicated (VAI)
May 27, 2016
Drugs · Drug Quality Assurance
None posted
Voluntary Action Indicated (VAI)
Nov 26, 2014
Drugs · Drug Quality Assurance
19 cited references
21 CFR 211.80(b). Handling and Storage to Prevent Contamination There was a failure to handle and store components at all times in a manner to prevent contamination.
21 CFR 211.25(a). Training , Education , Experience overall Employees engaged in the manufacture, processing, packing, and holding of a drug product lack the training required to perform their assigned functions.
21 CFR 211.194(a)(4). Data secured in course of each test Laboratory records do not include a complete record of all data secured in the course of each test, including all graphs and charts from laboratory instrumentation, properly identified to show the specific component, in-process material, and drug product tested. Electronic records are used, but they do not meet systems validation and audit trail requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records.
21 CFR 211.142(a). Quarantine - actual practice Drug products are not quarantined before being released by the quality control unit.
21 CFR 211.103. Actual vs. theoretical yields not determined Actual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate phase of manufacturing and processing of the drug product.
21 CFR 211.25(b). Supervisor Training/Education/Experience Individuals responsible for supervising the manufacture, processing, packing, and holding 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.
21 CFR 211.25(c). Inadequate number of personnel The number of qualified personnel is inadequate to supervise the manufacture, processing, packing, and holding of each drug product.
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 211.125(a). Strict control not exercised over labeling issued Strict control is not exercised over labeling issued for use in drug product labeling operations.
21 CFR 211.188. Prepared for each batch, include complete information Batch production and control records do not include complete information relating to the production and control of each batch.
21 CFR 211.166(a). Written program not followed The written stability testing program is not followed.
21 CFR 211.186(b)(7). Theoretical Yield and Percentages The master production and control records are deficient in that they do not include a statement of theoretical yield and minimum, maximum, and yield percentages.
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 211.100(b). Procedure Deviations Recorded and Justified Deviations from written production and process control procedures are not justified.
21 CFR 211.165(e). Test methods The accuracy, specificity, and reproducibility of test methods have not been established and documented.
21 CFR 211.160(b). Scientifically sound laboratory controls Laboratory controls do not include the establishment of scientifically sound and appropriate standards designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
21 CFR 211.160(b)(4). Calibration - at intervals, written program, remedial action The calibration of instruments is not done at suitable intervals in accordance with an established written program.
21 CFR 211.110(a). Control procedures to monitor and validate performance Control procedures are not established which 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.
21 CFR 211.160(a). Deviations from laboratory control requirements Deviations from written specifications are not justified.
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
Olive Branch, Mississippi, United States. Part of