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21 CFR 820.70(i) citations

Validation of changes to automated process software

FDA investigators cited 21 CFR 820.70(i) 409 times at 361 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Dec 4, 2025. 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
20264
202518
202421
202320
202217
20215
202011
201932
201827
201737

Recent citations

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

Inspection endedFacilityCountryObservation
Dec 4, 2025Cryo-Dynamics, Inc.United StatesSoftware validation activities and results for computers or automated data processing systems used as part of the quality system have not been documented.
Nov 26, 2025WEARLINQ INC.United StatesSoftware used as part of the quality system has not been validated for its intended use according to an established protocol.
Nov 5, 2025PNEO, LLCUnited StatesSoftware used as part of the quality system has not been adequately validated for its intended use according to an established protocol.
Oct 22, 2025LightwaveUnited StatesSoftware used as part of production and the quality system has not been validated for its intended use according to an established protocol.
Aug 5, 2025Carroll-Baccari IncUnited StatesSoftware used as part of has not been validated for its intended use according to an established protocol.
Jun 26, 2025Better Water LLCUnited StatesSoftware used as part of the quality system has not been validated for its intended use according to an established protocol.
Jun 18, 2025ActivePure Manufacturing LLC, A Wholly Owned Subsidiary Of ActivePure Technologies LLCUnited StatesSoftware used as part of production and the quality system has not been adequately validated for its intended use according to an established protocol.
Jun 6, 2025Preservation Solutions, Inc.United StatesSoftware validation activities and results for computers or automated data processing systems used as part of production have not been documented.
Jun 5, 2025MICROTEC SASFranceSoftware used as part of production and the quality system has not been validated for its intended use according to an established protocol.
May 29, 2025Morgan Newton Comp.United StatesSoftware used as part of production has not been validated for its intended use according to an established protocol.
May 23, 2025Somnomed IncUnited StatesSoftware used as part of the quality system has not been validated for its intended use according to an established protocol.
May 13, 2025Cranial Technologies, IncUnited StatesSoftware validation activities and results for computers or automated data processing systems used as part of production have not been adequately documented.
May 9, 2025Smaart Medical Systems, IncUnited StatesSoftware used as part of the quality system has not been validated for its intended use according to an established protocol.
Apr 28, 2025Truemed Group LLCUnited StatesSoftware used as part of the quality system has not been adequately validated for its intended use according to an established protocol.
Apr 16, 2025The Richline Group IncUnited StatesSoftware used as part of production has not been validated for its intended use according to an established protocol.
Mar 13, 2025Genesis Software Innovations LLC.United StatesSoftware used as part of the quality system has not been validated for its intended use according to an established protocol.
Mar 6, 2025Hard Manufacturing Co., Inc.United StatesSoftware used as part of production has not been adequately validated for its intended use according to an established protocol.
Dec 20, 2024RESET TECHNOLOGY CORPORATIONUnited StatesSoftware used as part of the quality system has not been validated for its intended use according to an established protocol.
Dec 4, 2024Okami Medical Inc.United StatesSoftware used as part of production has not been adequately validated for its intended use according to an established protocol.
Nov 7, 2024Commercial Plastics Kenosha LLCUnited StatesSoftware used as part of production and the quality system has not been adequately validated for its intended use according to an established protocol.
Nov 6, 2024iCE Neurosystems, Inc.United StatesSoftware used as part of production and the quality system has not been adequately validated for its intended use according to an established protocol.
Oct 25, 2024GlobalMed Holdings, LLCUnited StatesSoftware validation activities and results for computers or automated data processing systems used as part of the quality system have not been adequately documented.
Sep 20, 2024Charmcare Co. LtdKorea (the Republic of)Software used as part of production and the quality system has not been validated for its intended use according to an established protocol.
Sep 19, 2024ENESTIA BELGIUM NV (SHARP BELGIUM)BelgiumSoftware used as part of production has not been adequately validated for its intended use according to an established protocol.
Sep 18, 2024RESTECHUnited StatesSoftware used as part of the quality system has not been validated for its intended use according to an established protocol.

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