Home / CFR sections / 21 CFR 820.40(a)

21 CFR 820.40(a) citations

Not approved or obsolete document retrieval

FDA investigators cited 21 CFR 820.40(a) 406 times at 372 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Dec 18, 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
20261
202514
20248
20239
20228
20213
202011
201926
201819
201730

Recent citations

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

Inspection endedFacilityCountryObservation
Dec 18, 2025My Medical Store LLCUnited StatesThe documentation of approval of documents does not include the document approval date and the signature of the approving official.
Aug 18, 2025Donson Machine CompanyUnited StatesDocuments that were not approved were observed at a location where they are being used.
Aug 18, 2025Donson Machine CompanyUnited StatesThe document control procedures do not designate an individual to review documents for adequacy and approve them prior to issuance.
Aug 5, 2025Abiomed, Inc.United StatesDocuments were not approved by designated individual(s) prior to issuance .
Jul 30, 2025ZiphyCare, Inc.United StatesThe documentation of approval of documents does not include.
Jun 13, 2025Ion Medical, Inc.United StatesThe documentation of approval of documents does not include the document approval date and the signature of the approving official.
May 9, 2025The Feminina Group, Inc.United StatesDocuments were by designated individual(s) prior to issuance .
Apr 11, 2025Hansen Ophthalmic Development Laboratory Inc.United StatesDocuments were not reviewed by designated individual(s) prior to issuance .
Mar 26, 2025Innovize LLCUnited StatesDocuments were not approved by designated individual(s) prior to issuance .
Feb 3, 2025Lingraphicare America, Inc.United StatesThe documentation of approval of documents does not include the document approval date and the signature of the approving official.
Jan 28, 2025Ezar AI, Inc.United StatesThe documentation of approval of documents does not include the document approval date and the signature of the approving official.
Dec 19, 2024Koros USA, Inc.United StatesDocuments were not approved by designated individual(s) prior to issuance .
Dec 18, 2024Inman Orthodontic Laboratories, Inc.United StatesThe documentation of approval of documents does not include the document approval date and the signature of the approving official.
Nov 27, 2024MedHab, LLCUnited StatesDocuments that were obsolete were observed at a location where they are being used.
Nov 7, 2024WEIL INDUSTRIESFranceDocuments were not approved by designated individual(s) prior to issuance .
Jul 16, 2024Personal Medical Corp.United StatesDocuments were not available at all locations for which they are designated, used, or otherwise necessary.
Apr 5, 2024Skeletal Dynamics, Inc.United StatesDocuments that were not approved were observed at a location where they are being used.
Mar 15, 2024Taiji Medical Supplies Inc.United StatesDocuments that were obsolete were observed at a location where they are being used.
Jan 12, 2024The Richline Group IncUnited StatesThe documentation of approval of documents does not include the document approval date and the signature of the approving official.
Dec 13, 2023Midwest Eye Laboratories IncUnited StatesThe documentation of approval of documents does not include the document approval date and the signature of the approving official.
Dec 12, 2023TMJ Services LLCUnited StatesThe documentation of approval of documents does not include the document approval date and the signature of the approving official.
Dec 5, 2023Instrumed International IncUnited StatesDocuments were not available at all locations for which they are designated, used, or otherwise necessary.
Nov 17, 2023Oxygen Therapy InstituteUnited StatesThe documentation of approval of documents does not include the document approval date and the signature of the approving official.
Sep 28, 2023iScreen Vision, Inc.United StatesDocuments that were not approved and obsolete were observed at a location where they could be used.
Sep 28, 2023Swiss Bionic Solutions GmbHSwitzerlandDocuments were not approved by designated individual(s) prior to issuance .

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Search every Form 483 citation by company with the FDA 483 search, see all frequently cited CFR sections, or check one supplier with the free FDA compliance check.

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