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FDA establishment 3013584633, Beltsville, Maryland, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 2
Official action indicated: 0
Last inspection ended: Feb 11, 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 211.68(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.
21 CFR 211.80(d). Status of Each Lot Identified Each lot of components and drug product containers was not appropriately identified as to its status in terms of being quarantined, approved or rejected.
21 CFR 211.80(d). Disposition recorded by lot identification The distinctive code for each lot of components and closures is not used in recording the disposition of each lot.
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
Beltsville, Maryland, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.