Home / CFR sections / 21 CFR 211.160(a)

21 CFR 211.160(a) citations

Lab controls established, including changes

FDA investigators cited 21 CFR 211.160(a) 710 times at 576 facilities in the inspection citations FDA publishes, most recently in an inspection that ended May 15, 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
202618
202524
202429
202328
202224
202117
202023
201951
201850
201758

Recent citations

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

Inspection endedFacilityCountryObservation
May 15, 2026Canyon Rush, LLCUnited StatesEstablished laboratory control mechanisms are not followed.
May 8, 2026Sombra Cosmetics, IncUnited StatesThe establishment of specifications, standards, test procedures and laboratory control mechanisms including any changes thereto, are not drafted by the appropriate organizational unit and reviewed and approved by the…
Apr 29, 2026Samson Pharmaceuticals, IncUnited StatesThe establishment of laboratory control mechanisms including any changes thereto, are not drafted by the appropriate organizational unit.
Apr 24, 2026Hanlim Pharm Co. Ltd.Korea (the Republic of)Established test procedures are not documented at the time of performance.
Apr 22, 2026Alcami Carolinas CorporationUnited StatesThe establishment of laboratory control mechanisms including any changes thereto, are not drafted by the appropriate organizational unit and reviewed and approved by the quality control unit.
Apr 2, 2026Baxter Healthcare CorporationUnited StatesEstablished specifications, standards, sampling plans, test procedures and laboratory control mechanisms are not followed and documented at the time of performance.
Mar 26, 2026Westwood Laboratories, LLC.United StatesThe establishment of laboratory control mechanisms including any changes thereto, are not drafted by the appropriate organizational unit.
Mar 6, 2026Pharmaceutics International, Inc.United StatesDeviations from written standards are not recorded.
Feb 18, 2026Gilead Sciences, Inc.United StatesEstablished sampling plans are not followed.
Feb 6, 2026Eugia Pharma Specialities LimitedIndiaEstablished laboratory control mechanisms are not followed.
Feb 5, 2026Fenwal International, Inc.United StatesEstablished test procedures and laboratory control mechanisms are not followed.
Jan 30, 2026Element Materials Technology Oakland-ConcordUnited StatesEstablished test procedures are not followed.
Jan 21, 2026LPNA Group Inc.United StatesDeviations from written test procedures are not recorded and justified.
Jan 16, 2026PTI Georgia, LLCUnited StatesThe establishment of specifications, sampling plans, test procedures and laboratory control mechanisms including any changes thereto, are not drafted by the appropriate organizational unit and reviewed and approved by…
Nov 18, 2025Chartwell Pharmaceuticals Congers, LLCUnited StatesEstablished test procedures and laboratory control mechanisms are not followed and documented at the time of performance.
Oct 24, 2025CareFusion 213, LLCUnited StatesEstablished test procedures are not documented at the time of performance.
Oct 17, 2025Diamond Wipes International, Inc.United StatesEstablished test procedures and laboratory control mechanisms are not documented at the time of performance.
Oct 2, 2025OraLabs LLCUnited StatesEstablished specifications are not followed.
Sep 12, 2025Corza Medical Distribution GmbH, Austria BranchAustriaEstablished test procedures are not followed.
Sep 5, 2025Central Admixture Pharmacy Services, Inc.United StatesEstablished standards, sampling plans and test procedures are not followed.
Sep 4, 2025Sparsha Pharma Usa IncUnited StatesThe establishment of laboratory control mechanisms including any changes thereto, are not reviewed and approved by the quality control unit.
Aug 7, 2025Pace Analytical Inc.United StatesEstablished standards and laboratory control mechanisms are not followed and documented at the time of performance.
Jul 31, 2025Telix IsoTherapeutics Group, Inc.United StatesThe establishment of test procedures and laboratory control mechanisms including any changes thereto, are not drafted by the appropriate organizational unit and reviewed and approved by the quality control unit.
Jul 30, 2025Tower Laboratories, Ltd.United StatesEstablished laboratory control mechanisms are not followed.
Jun 18, 2025Seaway Pharma Inc.United StatesEstablished laboratory control mechanisms are not followed.

Search more

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.