21 CFR 114.83 citations

Scheduled process establishment

FDA investigators cited 21 CFR 114.83 405 times at 339 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Sep 18, 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
202619
202525
202417
202312
202215
20214
20206
201928
201823
201727

Recent citations

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

Inspection endedFacilityCountryObservation
Sep 18, 2026The Kroger CompanyUnited StatesA scheduled process was not established by a qualified person who has expert knowledge acquired through appropriate training and experience in acidification and processing of acidified foods.
Aug 31, 2026Dongseo Wellbeing CorporationKorea (the Republic of)A scheduled process was not established by a qualified person who has expert knowledge acquired through appropriate training and experience in acidification and processing of acidified foods.
Jul 30, 2026Pacific Exchange Distributors, LLCUnited StatesA scheduled process was not established by a qualified person who has expert knowledge acquired through appropriate training and experience in acidification and processing of acidified foods.
Jul 17, 2026Probst Preserves, Inc.United StatesA scheduled process was not established by a qualified person who has expert knowledge acquired through appropriate training and experience in acidification and processing of acidified foods.
Jun 29, 2026Gadal Laboratories Inc.United StatesA scheduled process was not established by a qualified person who has expert knowledge acquired through appropriate training and experience in acidification and processing of acidified foods.
May 29, 2026Chef Merito, LLCUnited StatesA scheduled process was not established by a qualified person who has expert knowledge acquired through appropriate training and experience in acidification and processing of acidified foods.
Apr 22, 2026ALIMENTOS GAVELLE S.A. DE C.VMexicoA scheduled process was not established by a qualified person who has expert knowledge acquired through appropriate training and experience in acidification and processing of acidified foods.
Apr 17, 2026Total Life ChangesUnited StatesA scheduled process was not established by a qualified person who has expert knowledge acquired through appropriate training and experience in acidification and processing of acidified foods.
Apr 8, 2026Padagis US LLCUnited StatesA scheduled process was not established by a qualified person who has expert knowledge acquired through appropriate training and experience in acidification and processing of acidified foods.
Apr 1, 2026Rico-Chef Food Products, Inc.United StatesA scheduled process was not established by a qualified person who has expert knowledge acquired through appropriate training and experience in acidification and processing of acidified foods.
Mar 24, 2026Dona Janna S.A.S. CorporationEcuadorA scheduled process was not established by a qualified person who has expert knowledge acquired through appropriate training and experience in acidification and processing of acidified foods.
Mar 12, 2026Tarami Corporation Ltd.JapanA scheduled process was not established by a qualified person who has expert knowledge acquired through appropriate training and experience in acidification and processing of acidified foods.
Jan 21, 2026Mima's Country KitchenUnited StatesA scheduled process was not established by a qualified person who has expert knowledge acquired through appropriate training and experience in acidification and processing of acidified foods.
Jan 20, 2026LINGHAM & SONS (MALAYSIA) SDN. BHD.MalaysiaA scheduled process was not established by a qualified person who has expert knowledge acquired through appropriate training and experience in acidification and processing of acidified foods.
Jan 12, 2026H2 BEV, LLCUnited StatesA scheduled process was not established by a qualified person who has expert knowledge acquired through appropriate training and experience in acidification and processing of acidified foods.
Jan 12, 2026H2 RENU, INCUnited StatesA scheduled process was not established by a qualified person who has expert knowledge acquired through appropriate training and experience in acidification and processing of acidified foods.
Dec 11, 2025Prima Foods International, Inc.United StatesA scheduled process was not established by a qualified person who has expert knowledge acquired through appropriate training and experience in acidification and processing of acidified foods.
Dec 5, 2025Ahmetoglu Konserve Ins Akaryakit Pazarlama Ithalat Ihracat Sanayi TicaretTurkeyA scheduled process was not established by a qualified person who has expert knowledge acquired through appropriate training and experience in acidification and processing of acidified foods.
Oct 28, 2025Carma S.R.L.ItalyA scheduled process was not established by a qualified person who has expert knowledge acquired through appropriate training and experience in acidification and processing of acidified foods.
Sep 24, 2025Namias Of Arizona, Inc.United StatesA scheduled process was not established by a qualified person who has expert knowledge acquired through appropriate training and experience in acidification and processing of acidified foods.
Sep 18, 2025GOOT ESSA, LLCUnited StatesA scheduled process was not established by a qualified person who has expert knowledge acquired through appropriate training and experience in acidification and processing of acidified foods.
Aug 27, 2025Adept Life Sciences, LLCUnited StatesA scheduled process was not established by a qualified person who has expert knowledge acquired through appropriate training and experience in acidification and processing of acidified foods.
Aug 7, 2025PulpoUnited StatesA scheduled process was not established by a qualified person who has expert knowledge acquired through appropriate training and experience in acidification and processing of acidified foods.
Aug 1, 2025CLVM LLCUnited StatesA scheduled process was not established by a qualified person who has expert knowledge acquired through appropriate training and experience in acidification and processing of acidified foods.
Jul 16, 2025EVG Extracts LLCUnited StatesA scheduled process was not established by a qualified person who has expert knowledge acquired through appropriate training and experience in acidification and processing of acidified foods.

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.