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21 CFR 113.100(b) citations

Review of processing and production records

FDA investigators cited 21 CFR 113.100(b) 321 times at 244 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Apr 20, 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
20265
20259
20247
202320
20228
20211
20205
201913
201819
201717

Recent citations

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

Inspection endedFacilityCountryObservation
Apr 20, 2026West Lake Food CorporationUnited StatesA processing and production record was not signed or initialed and dated by the reviewer.
Dec 3, 2025Dae Shin Mul San Co., Ltd.Korea (the Republic of)A processing record was not reviewed within 1 working day after the actual process and before shipment or release for distribution to determine completeness of the record and to ensure that the product received the…
Oct 29, 2025Calugi, SRLItalyA processing record was not signed or initialed by the reviewer.
Oct 27, 2025Fuji Shokuhin Co., Ltd.JapanA processing record was not dated by the reviewer.
Oct 20, 2025Tartufi Bianconi, S.R.L.ItalyA processing record was not dated by the reviewer.
Jul 25, 2025Faropeixe Comercio Geral De Peixe LdaPortugalA processing record was not signed or initialed and dated by the reviewer.
Jul 2, 2025PVG FOOD HELLAS SAGreeceA processing record was not reviewed by a representative of plant management to determine whether the product received the scheduled process.
May 27, 2025Shinseon F&V Co. Ltd.Korea (the Republic of)A processing and production record form was not signed or initialed by a processing system operator or other designated person.
Jan 14, 2025Porttable Produtos Alimentares, Lda.PortugalTemperature-recording device records were not identified by data necessary to correlate the temperature-recording device with the record of lots processed.
Jan 14, 2025Porttable Produtos Alimentares, Lda.PortugalA processing record was not reviewed by a representative of plant management qualified by suitable training or experience to determine completeness of the record and whether the product received the scheduled process.
Jan 14, 2025Porttable Produtos Alimentares, Lda.PortugalA processing and production record form was not signed or initialed by a processing system operator or other designated person.
Oct 30, 2024Tu Thao Export Straw Mushroom Food Processing Co., Ltd.VietnamA processing record was not dated by the reviewer.
Oct 24, 2024Nam Duong International Foodstuff CorporationVietnamA processing record was not signed or initialed and dated by the reviewer.
Oct 15, 2024V.U.A AGRICULTURE CORPORATIONVietnamA production record was not reviewed within 1 working day after the actual process to determine completeness of the record and to ensure that the product received the scheduled process.
Aug 23, 2024Baldwin Richardson Foods Pennsauken, LLCUnited StatesA processing and production record was not reviewed by a representative of plant management to determine completeness of the record and whether the product received the scheduled process.
Jun 5, 2024UTC Foods CorporationTaiwanTemperature-recording device records were not identified by data necessary to correlate the temperature-recording device with the record of lots processed.
May 16, 2024Ya Ya Foods USA LLCUnited StatesA processing record was not reviewed by a representative of plant management to determine completeness of the record and whether the product received the scheduled process.
Mar 19, 2024The Kroger CompanyUnited StatesA processing and production record was not reviewed within 1 working day after the actual process to determine completeness of the record and to ensure that the product received the scheduled process.
Mar 12, 2024KIBUN FOODS INC. TOKYO FACTORYJapanTemperature-recording device records were not identified by retort number.
Oct 11, 2023Potenergy Natural FoodsUnited StatesA processing and production record was not reviewed within 1 working day after the actual process and before shipment or release for distribution to determine completeness of the record and to ensure that the product…
Oct 11, 2023Potenergy Natural FoodsUnited StatesA processing and production record was not reviewed by a representative of plant management qualified by suitable training or experience to determine whether the product received the scheduled process.
Aug 8, 2023Schreiber Foods, Inc.United StatesA processing and production record was not reviewed by a representative of plant management qualified by suitable training or experience to determine completeness of the record and whether the product received the…
Jun 22, 2023Blackeye Beverage LLCUnited StatesA processing record was not reviewed by a representative of plant management qualified by suitable training or experience to determine completeness of the record.
Jun 5, 2023Regal Kitchen Foods LimitedIndiaA processing and production record was not dated by the reviewer.
Jun 5, 2023Regal Kitchen Foods LimitedIndiaTemperature-recording device records were not identified by data necessary to correlate the temperature-recording device with the record of lots processed.

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