Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
FDA establishment 3006642851, Jonesboro, Arkansas, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 3
Official action indicated: 0
Last inspection ended: Sep 15, 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 211.22(d). Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not fully followed.
21 CFR 211.192. No written record of investigation Written records are not made of investigations into the failure of a batch or any of its components to meet specifications.
21 CFR 211.194(a)(2). Reference and method not stated Laboratory records of methods of testing used do not provide the reference when employing methods in.
21 CFR 211.166(a)(2). Stability sample storage conditions described The written stability program for drug products does not describe the storage conditions for samples retained for testing.
21 CFR 211.194(a)(2). Suitability of testing methods verified The suitability of all testing methods is not verified under actual conditions of use.
21 CFR 211.22(c). Approve or reject procedures or specs The quality control unit lacks responsibility to approve and reject all procedures or specifications impacting on the quality of drug products.
Voluntary Action Indicated (VAI)
Mar 10, 2020
Drugs · Drug Quality Assurance
2 cited references
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 211.192. Written record of investigation incomplete Written records of investigations into the failure of a batch or any of its components to meet specifications do not always include the conclusions and follow-up.
Voluntary Action Indicated (VAI)
Jul 10, 2015
Drugs · Drug Quality Assurance
6 cited references
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 211.142. Written warehousing procedures established/followed Procedures describing the warehousing of drug products are not established.
21 CFR 211.56(a). Sanitation--buildings not clean, free of infestation Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in a clean and sanitary condition.
21 CFR 211.67(a). Cleaning / Sanitizing / Maintenance Equipment and utensils are not cleaned and sanitized at appropriate intervals to prevent malfunctions that would alter the safety, identity, strength, quality or purity of the drug product.
21 CFR 211.65(a). Equipment construction - reactive surfaces Equipment surfaces that contact drug products are reactive, additive or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.
21 CFR 211.180(e)(1). Review of representative number of batches Written procedures are not followed for evaluations conducted at least annually to review records associated with a representative number of batches, whether approved or rejected.
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
Jonesboro, Arkansas, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.