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FDA establishment 3004026589, Plainfield, Indiana, 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: Apr 3, 2026
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 211.180(e)(2). Items to cover on annual reviews Written procedures are not established for evaluations done at least annually and including provisions for a review of complaints, recalls and returned or salvaged drug products.
21 CFR 211.198(a). Procedures to be written and followed Procedures describing the handling of all written and oral complaints regarding a drug product are not followed.
21 CFR 211.25(a). Training , Education , Experience overall Employees engaged in the packing of a drug product lack the training required to perform their assigned functions.
21 CFR 211.192. Investigations of discrepancies, failures There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
21 CFR 211.68(a). Calibration/Inspection/Checking not done Routine inspection of mechanical equipment is not performed according to a written program designed to assure proper performance.
Voluntary Action Indicated (VAI)
Mar 4, 2022
Drugs · Drug Quality Assurance
None posted
Voluntary Action Indicated (VAI)
Mar 17, 2017
Drugs · Drug Quality Assurance
1 cited reference
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.
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
Plainfield, Indiana, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.