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FDA establishment 1676462, Sherman, Texas, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations and its recalls since 2016.
Inspections: 6
Official action indicated: 0
Last inspection ended: Aug 23, 2024
Warning letters: 0
Recalls since 2016: 3
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 630.10(g)(1). Proof Of Identity Failure to obtain from the donor on the day of donation a postal address where the donor may be contacted for 8 weeks after donation.
21 CFR 606.60(a). Maintain and clean equipment Failure to maintain equipment used in the collection, processing, storage and distribution of blood and blood products.
21 CFR 606.40. Clean & orderly Failure to maintain facilities in a clean and orderly manner.
21 CFR 606.60(b). Equipment calibration frequency Equipment used in the collection, processing and storage and distribution of blood and blood components is not observed, standardized and calibrated with at least the frequency required.
Voluntary Action Indicated (VAI)
May 3, 2019
Biologics · Blood and Blood Products
2 cited references
21 CFR 606.160(a)(1). Concurrent documentation Records are not concurrently maintained with the performance of each significant step in the processing of each unit of blood and blood components so that all steps can be clearly traced.
21 CFR 630.30(b)(2). Unsuitable donation - defer testing Failure to properly defer the donor of blood and blood components when the donation was unsuitable based on the results of the donor eligibility process.
Voluntary Action Indicated (VAI)
Feb 20, 2015
Biologics · Blood and Blood Products
None posted
No Action Indicated (NAI)
Dec 13, 2012
Biologics · Blood and Blood Products
None posted
No Action Indicated (NAI)
Dec 9, 2010
Biologics · Blood and Blood Products
None posted
No Action Indicated (NAI)
Jan 21, 2009
Biologics · Blood and Blood Products
2 cited references
21 CFR 606.140(a). Establishment of spec., standards, and test procedures Failure to establish scientifically sound and appropriate specifications, standards and test procedures to assure that blood and blood components are safe, pure, potent and effective.
21 CFR 606.100(a). SOP compliance Failure of the Standard Operating Procedure to comply with additional standards in 21 CFR 640.
Voluntary Action Indicated (VAI)
Recalls
3 drug, device and biologic recalls since 2016, newest first; 0 Class I
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
Sherman, Texas, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations and its recalls since 2016.