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21 CFR 110.35(d)(5) citations

Shown to be effective

FDA investigators cited 21 CFR 110.35(d)(5) 708 times at 618 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Feb 7, 2020. 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
20201
20194
201819
201758
201648
201563
201465
201359
201288
2011132

Recent citations

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

Inspection endedFacilityCountryObservation
Feb 7, 2020Carfagnas IncUnited StatesThe procedure used for cleaning and sanitizing of equipment and utensils has not been shown to provide adequate sanitizing treatment.
Aug 15, 2019Sugar Daddy, LTDUnited StatesSanitizing agents are inadequate under conditions of use.
Jul 1, 2019Euro USA, LLCUnited StatesThe procedure used for cleaning of equipment has not been shown to provide adequate cleaning.
May 29, 2019LSG Sky Chefs, LLCUnited StatesThe machine used for sanitizing of equipment has not been shown to provide adequate sanitizing treatment.
Apr 3, 2019Fashion FabsIndiaThe procedure used for sanitizing of has not been shown to provide adequate sanitizing treatment.
Sep 27, 2018NICO MEXI FOODS INCUnited StatesThe procedure used for cleaning of equipment and utensils has not been shown to provide adequate cleaning.
Aug 8, 2018Sorento Import Export LLCUnited StatesThe procedure used for sanitizing of equipment and utensils has not been shown to provide adequate sanitizing treatment.
Aug 6, 2018Juices International, Inc.United StatesSanitizing agents are inadequate under conditions of use.
Jun 20, 2018Hostetlers Catering IncUnited StatesSanitizing agents are inadequate and unsafe under conditions of use.
Jun 12, 2018M&B Distributors IncUnited StatesSanitizing agents are inadequate and unsafe under conditions of use.
Jun 1, 2018Perla Del Sur Foods L.L.C.United StatesThe procedure used for cleaning and sanitizing of equipment and utensils has not been shown to provide adequate cleaning and sanitizing treatment.
May 16, 2018Dallmann Confection Inc.United StatesSanitizing agents are inadequate under conditions of use.
May 8, 2018Trenary Toast Bakery IncUnited StatesThe procedure used for sanitizing of equipment and utensils has not been shown to provide adequate sanitizing treatment.
Apr 20, 2018Tortilleria ProvinciaUnited StatesSanitizing agents are inadequate under conditions of use.
Apr 11, 2018Evo Kitchen, LLC.United StatesThe procedure used for cleaning and sanitizing of equipment has not been shown to provide adequate cleaning and sanitizing treatment.
Dec 28, 2017Sekero International, Inc.United StatesThe procedure used for cleaning and sanitizing of equipment and utensils has not been shown to provide adequate cleaning and sanitizing treatment.
Dec 22, 2017Snappy Dog Foods, IncUnited StatesThe procedure used for sanitizing of equipment and utensils has not been shown to provide adequate sanitizing treatment.
Dec 22, 2017Sprout Creek Farm, Inc.United StatesThe procedure used for cleaning and sanitizing of equipment and utensils has not been shown to provide adequate cleaning and sanitizing treatment.
Dec 19, 2017Cooperstown Cheese Company, LLCUnited StatesSanitizing agents are inadequate under conditions of use.
Dec 14, 2017Seong Hoon KimUnited StatesThe procedure used for cleaning and sanitizing of equipment and utensils has not been shown to provide adequate cleaning and sanitizing treatment.
Nov 17, 2017Hinsdale & Foster Provisions, LLCUnited StatesSanitizing agents are inadequate under conditions of use.
Nov 16, 2017Stevens Family Bakery & Orchard LLCUnited StatesThe procedure used for cleaning and sanitizing of equipment has not been shown to provide adequate cleaning and sanitizing treatment.
Oct 26, 2017Frost Bite NoveltiesUnited StatesThe machine used for sanitizing of equipment has not been shown to provide adequate sanitizing treatment.
Oct 25, 2017La Dona, IncUnited StatesThe procedure used for of equipment and utensils has not been shown to provide adequate sanitizing treatment.
Sep 26, 2017Surata Soyfoods IncUnited StatesThe procedure used for sanitizing of utensils has not been shown to provide adequate sanitizing treatment.

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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.