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21 CFR 123.8(a)(2)(ii) citations

Calibration - adequacy

FDA investigators cited 21 CFR 123.8(a)(2)(ii) 687 times at 560 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Oct 9, 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
20271
202616
202516
20249
202313
202213
20218
202013
201935
201832

Recent citations

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

Inspection endedFacilityCountryObservation
Oct 9, 2026Usarg, IncUnited StatesYour process monitoring equipment is not calibrated to ensure that it reads accurately.
Sep 22, 2026Nital Trading Company IncUnited StatesYour process monitoring equipment is not calibrated to ensure that it reads accurately.
Jun 22, 2026Fresh Seafood Distributors, LLCUnited StatesYour process monitoring equipment is not calibrated to ensure that it reads accurately.
Jun 12, 2026Ninans Pvt LtdIndiaYour process monitoring equipment is not calibrated to ensure that it reads accurately.
Jun 9, 2026Hosoda Bros IncUnited StatesYour process monitoring equipment is not calibrated to ensure that it reads accurately.
May 26, 2026MFM Seafood IncUnited StatesYour process monitoring equipment is not calibrated to ensure that it reads accurately.
May 7, 2026SEAWAY SEAFOOD AND SERVICES LLCUnited StatesYour process monitoring equipment is not calibrated to ensure that it reads accurately.
Apr 28, 2026Kosher First LLCUnited StatesYour process monitoring equipment is not calibrated to ensure that it reads accurately.
Apr 7, 2026Supreme Distributers Inc.United StatesYour process monitoring equipment is not calibrated to ensure that it reads accurately.
Mar 20, 2026FILARETOS BROS CO.GreeceYour process monitoring equipment is not calibrated to ensure that it reads accurately.
Mar 18, 2026SBN Partners LLCUnited StatesYour process monitoring equipment is not calibrated to ensure that it reads accurately.
Feb 20, 2026Southeast Asian Food Product, Inc.United StatesYour process monitoring equipment is not calibrated to ensure that it reads accurately.
Feb 18, 2026Out Of The Blue Wholesale LLCUnited StatesYour process monitoring equipment is not calibrated to ensure that it reads accurately.
Feb 5, 2026Thuan Hung Company LimitedVietnamYour process monitoring equipment is not calibrated to ensure that it reads accurately.
Jan 15, 2026Chunghae FoodKorea (the Republic of)Your process monitoring equipment is not calibrated to ensure that it reads accurately.
Dec 15, 2025Montauk Seafood Co. Inc.United StatesYour process monitoring equipment is not calibrated to ensure that it reads accurately.
Nov 10, 2025Carmenita Seafood House, Inc.United StatesYour process monitoring equipment is not calibrated to ensure that it reads accurately.
Sep 3, 2025LaFond's Fish Market, LLCUnited StatesYour process monitoring equipment is not calibrated to ensure that it reads accurately.
Aug 29, 2025Tempano SeafoodUnited StatesYour process monitoring equipment is not calibrated to ensure that it reads accurately.
Aug 18, 2025Patagonia Distribution, LLCUnited StatesYour process monitoring equipment is not calibrated to ensure that it reads accurately.
Aug 14, 2025Pacific Seafood - Seattle, LLCUnited StatesYour process monitoring equipment is not calibrated to ensure that it reads accurately.
Jul 16, 2025Ocean Queen USA, Inc.United StatesYour process monitoring equipment is not calibrated to ensure that it reads accurately.
Jul 8, 2025South Bay Cold LLCUnited StatesYour process monitoring equipment is not calibrated to ensure that it reads accurately.
May 6, 2025Blue Marine, Inc.United StatesYour process monitoring equipment is not calibrated to ensure that it reads accurately.
May 2, 2025Carolina Seafoods, Inc.United StatesYour process monitoring equipment is not calibrated to ensure that it reads accurately.

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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.