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21 CFR 211.68(a) citations

Written calibration / inspection records not kept

FDA investigators cited 21 CFR 211.68(a) 816 times at 697 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Jul 22, 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
202620
202538
202426
202328
202231
202121
202026
201951
201852
201758

Recent citations

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

Inspection endedFacilityCountryObservation
Jul 22, 2026Neilmed Pharmaceuticals IncUnited StatesRoutine calibration of electronic equipment is not performed according to a written program designed to assure proper performance.
Jul 14, 2026Aspen SA Sterile Operations (Pty) Ltd.South AfricaRoutine checking of automatic and mechanical equipment is not performed according to a written program designed to assure proper performance.
Jun 30, 2026Meridian Medical Technologies, LLC A Subsidiary Of Kindeva Drug Delivery, L.P.United StatesRoutine checking of automatic equipment is not performed according to a written program designed to assure proper performance.
Jun 26, 2026Hetero Labs Ltd. Unit VIIndiaRoutine inspection and checking of automatic, mechanical and electronic equipment is not performed according to a written program designed to assure proper performance.
May 14, 2026Blessings InternationalUnited StatesRoutine calibration of automatic and electronic equipment is not performed according to a written program designed to assure proper performance.
May 8, 2026Sombra Cosmetics, IncUnited StatesRoutine calibration, inspection and checking of automatic, mechanical and electronic equipment is not performed according to a written program designed to assure proper performance.
May 4, 2026CTK OTC Laboratories LLCUnited StatesRoutine calibration and checking of automatic and mechanical equipment is not performed according to a written program designed to assure proper performance.
Apr 27, 2026Similasan AGSwitzerlandRoutine checking of mechanical and electronic equipment is not performed according to a written program designed to assure proper performance.
Apr 9, 2026Global Packaging Systems, IncUnited StatesRoutine calibration of electronic equipment is not performed according to a written program designed to assure proper performance.
Apr 3, 2026MD Logistics, LLCUnited StatesRoutine inspection of mechanical equipment is not performed according to a written program designed to assure proper performance.
Mar 20, 2026Eosera, Inc.United StatesRoutine calibration of automatic and electronic equipment is not performed according to a written program designed to assure proper performance.
Mar 10, 2026Cosmetic Lab, Inc.United StatesRecords of the calibration checks of automatic, mechanical or electronic equipment, including computers or related systems are not maintained.
Feb 12, 2026Tropical Seas, Inc.United StatesRoutine calibration of mechanical equipment is not performed according to a written program designed to assure proper performance.
Feb 3, 2026Iso-Tex Diagnostics, Inc.United StatesRoutine inspection and checking of automatic and mechanical equipment is not performed according to a written program designed to assure proper performance.
Jan 30, 2026Element Materials Technology Oakland-ConcordUnited StatesRoutine inspection of mechanical equipment is not performed according to a written program designed to assure proper performance.
Jan 23, 2026Island Kinetics, Inc. D.B.A. CoValence LaboratoriesUnited StatesRoutine inspection and checking of automatic and mechanical equipment is not performed according to a written program designed to assure proper performance.
Jan 16, 2026ABS CorporationUnited StatesRoutine calibration of automatic and electronic equipment is not performed according to a written program designed to assure proper performance.
Nov 3, 2025Beauty Manufacturing Solutions Corp.United StatesRoutine calibration of electronic equipment is not performed according to a written program designed to assure proper performance.
Oct 29, 2025JP Packaging L.L.C.United StatesRoutine calibration of electronic equipment is not performed according to a written program designed to assure proper performance.
Oct 16, 2025Liquipak CorporationUnited StatesRoutine calibration and inspection of electronic equipment is not performed according to a written program designed to assure proper performance.
Sep 26, 2025Intercos America, Inc.United StatesRoutine inspection and checking of automatic, mechanical and electronic equipment is not performed according to a written program designed to assure proper performance.
Sep 15, 2025ChiRhoClin, IncUnited StatesRoutine calibration of equipment is not performed according to a written program designed to assure proper performance.
Sep 15, 2025Pharbest Pharmaceuticals, Inc.United StatesRoutine calibration, inspection and checking of mechanical equipment is not performed according to a written program designed to assure proper performance.
Aug 29, 2025Bio-Medical Pharmaceutical Manufacturing CorporationUnited StatesRoutine calibration and inspection of equipment is not performed according to a written program designed to assure proper performance.
Aug 28, 2025RC Outsourcing, LLCUnited StatesRoutine calibration of automatic, mechanical and electronic equipment is not performed according to a written program designed to assure proper performance.

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