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21 CFR 211.160(b)(4) citations

Written calibration procedures

FDA investigators cited 21 CFR 211.160(b)(4) 554 times at 462 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Sep 4, 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
202613
202513
202417
202319
202212
20218
202010
201927
201847
201741

Recent citations

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

Inspection endedFacilityCountryObservation
Sep 4, 2026ACTA Laboratories, Inc.United StatesThe calibration of apparatus and recording devices is not done at suitable intervals in accordance with an established written program.
Apr 29, 2026Samson Pharmaceuticals, IncUnited StatesThe calibration of instruments is not done at suitable intervals in accordance with an established written program.
Mar 26, 2026Westwood Laboratories, LLC.United StatesThe use of instruments not meeting established specifications was observed.
Feb 27, 2026Gasco Industrial Corp.United StatesWritten calibration procedures for instruments, apparatus, gauges, and recording devices are deficient in that they do not include specific directions, schedules, limits for accuracy and precision and provisions for…
Feb 3, 2026Iso-Tex Diagnostics, Inc.United StatesThe calibration of instruments and recording devices is not done at suitable intervals in accordance with an established written program.
Jan 16, 2026Innovatical Laboratories LlcUnited StatesTest devices are deficient in that instruments not meeting established specifications are used. Electronic records are used, but they do not meet requirements to ensure that they are trustworthy, reliable and generally…
Dec 19, 2025KaryoLogic IncUnited StatesProcedures describing the calibration of instruments, apparatus, gauges and recording devices are not written or followed.
Dec 19, 2025Micron IncUnited StatesProcedures describing the calibration of instruments, apparatus, gauges and recording devices are not written or followed.
Dec 4, 2025St Mary's Medical Park PharmacyUnited StatesWritten calibration procedures for instruments, apparatus, gauges, and recording devices are deficient in that they do not include specific directions, schedules, limits for accuracy and precision and provisions for…
Nov 18, 2025Mart Specialities Lab LLPIndiaTest devices are deficient in that instruments and apparatus not meeting established specifications are used.
Oct 23, 2025EO Products, LLCUnited StatesProcedures describing the calibration of instruments, apparatus, gauges and recording devices are not written or followed.
Oct 14, 2025Hill Dermaceuticals, Inc.United StatesThe calibration of instruments, apparatus, gauges and recording devices is not done at suitable intervals in accordance with an established written program.
Oct 9, 2025Precare CorpUnited StatesThe calibration of instruments is not done at suitable intervals.
Sep 26, 2025Nelson Laboratories, LLCUnited StatesTest devices are deficient in that instruments not meeting established specifications are used.
Sep 25, 2025PML NYC, LLCUnited StatesThe calibration of instruments, apparatus, gauges and recording devices is not done at suitable intervals in accordance with an established written program.
Sep 16, 2025Microbiological Testing & Consulting, LLCUnited StatesThe calibration of gauges and recording devices is not done at suitable intervals in accordance with an established written program.
Sep 15, 2025Pharbest Pharmaceuticals, Inc.United StatesProcedures describing the calibration of instruments, apparatus, gauges and recording devices are not written or followed.
Jun 30, 2025Silliker, Inc.United StatesThe calibration of apparatus and recording devices is not done at suitable intervals.
Jun 12, 2025Hysan Pharmaceutical Co., Ltd.Hong Kong SARThe calibration of instruments and gauges is not done at suitable intervals in accordance with an established written program.
Jun 4, 2025Kappa Laboratories, Inc.United StatesProcedures describing the calibration of instruments, apparatus, gauges and recording devices are not written or followed and deficiently written or followed.
Apr 28, 2025Soaptronic LLCUnited StatesThe calibration of gauges is not done at suitable intervals in accordance with an established written program.
Mar 21, 2025Formulation Technology LLCUnited StatesThe calibration of instruments and gauges is not done at suitable intervals.
Feb 12, 2025AVASOL LLCUnited StatesProcedures describing the calibration of instruments, apparatus, gauges and recording devices are not written or followed.
Jan 31, 2025Alcami Carolinas CorporationUnited StatesWritten calibration procedures for instruments, apparatus, gauges, and recording devices are deficient in that they do not include specific schedules, limits for accuracy and precision and provisions for remedial action…
Dec 6, 2024Pharmaceutics International IncUnited StatesProcedures describing the calibration of instruments, apparatus, gauges and recording devices are not written or followed.

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