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21 CFR 820.250(b) citations

Sampling plans

FDA investigators cited 21 CFR 820.250(b) 331 times at 307 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Jan 16, 2026. A citation is an observation listed on Form FDA 483 at the end of an inspection; it is not a final agency decision.

Citations by fiscal year

FDA fiscal yearCitations
20263
202520
202412
202312
202212
20215
20208
201916
201831
201726

Recent citations

The latest inspections that cited this section. Facility names link to each facility's FDA record.

Inspection endedFacilityCountryObservation
Jan 16, 2026Marson Medical, Inc.United StatesSampling plans are not based on valid statistical rationale.
Jan 13, 2026Nuclein LLCUnited StatesSampling plans are not based on valid statistical rationale.
Nov 24, 2025Creative Foam Corporation - BremenUnited StatesSampling plans are not written and based on valid statistical rationale.
Sep 18, 2025Jabil Tuttlingen Manufacturing GMBHGermanySampling plans are not based on valid statistical rationale.
Sep 5, 2025Keter Canada, Inc.CanadaProcedures to ensure sampling methods are adequate for their intended use have not been established.
Aug 26, 2025Magellan Diagnostics, Inc.United StatesSampling plans are not written and based on valid statistical rationale.
Aug 25, 2025Varex Imaging CorporationUnited StatesProcedures to ensure sampling methods are adequate for their intended use have not been adequately established.
Jul 30, 2025Serim Research CorporationUnited StatesSampling plans are not based on valid statistical rationale.
Jul 3, 2025Caltag Medsystems LtdUnited KingdomProcedures to ensure sampling methods are adequate for their intended use have not been adequately established.
Jun 18, 2025Nelson Enviromental Technologies, Inc.United StatesProcedures to ensure sampling methods are adequate for their intended use have not been established.
Jun 2, 2025American Contract Systems IncUnited StatesProcedures to ensure sampling methods are adequate for their intended use have not been adequately established.
Apr 30, 2025Transfer Technology, Inc.United StatesSampling plans are not based on valid statistical rationale.
Apr 23, 2025Richard-Allan Scientific CompanyUnited StatesSampling plans are not written and based on valid statistical rationale.
Apr 16, 2025The Richline Group IncUnited StatesProcedures to ensure sampling methods are adequate for their intended use have not been adequately established.
Apr 10, 2025Magnamed Tecnologia Medica S/ABrazilSampling plans are not based on valid statistical rationale.
Mar 12, 2025Industrial Woodworking Corp.United StatesSampling plans are not written and based on valid statistical rationale.
Feb 27, 2025Dimension Inx Corp.United StatesProcedures to ensure sampling methods are adequate for their intended use have not been established.
Jan 23, 2025Aju Medical Co., Ltd.Korea (the Republic of)Sampling plans are not based on valid statistical rationale.
Jan 21, 2025TruAbutment Inc.United StatesSampling plans are not based on valid statistical rationale.
Nov 21, 2024Granite Microsystems, Inc.United StatesSampling plans are not based on valid statistical rationale.
Nov 6, 2024AXILUM ROBOTICS SASFranceProcedures to ensure sampling methods are adequate for their intended use have not been established.
Oct 31, 2024BizLink Robotic Solutions FranceFranceProcedures to ensure sampling methods are adequate for their intended use have not been adequately established.
Oct 3, 2024Mannkind CorporationUnited StatesSampling plans are not based on valid statistical rationale.
Sep 6, 2024Precision Medical Technologies, Inc.United StatesProcedures to ensure sampling methods are adequate for their intended use have not been adequately established.
Aug 22, 2024Model SolutionKorea (the Republic of)Sampling plans are not based on valid statistical rationale.

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Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.