21 CFR 110.80(b)(8) citations

Metal / extraneous materials

FDA investigators cited 21 CFR 110.80(b)(8) 448 times at 403 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Dec 14, 2018. 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
20191
201812
201756
201647
201544
201425
201348
201244
201183
201047

Recent citations

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

Inspection endedFacilityCountryObservation
Dec 14, 2018Pankaj Exports Private LimitedIndiaFailure to take effective measures to protect against the inclusion of extraneous material in food.
Aug 23, 2018Anahuac, Inc.United StatesFailure to take effective measures to protect against the inclusion of metal and extraneous material in food.
Jun 22, 2018Productos Ole Del Ecuador Productosole Cia LtdaEcuadorFailure to take effective measures to protect against the inclusion of metal in food.
Jun 12, 2018M&B Distributors IncUnited StatesFailure to take effective measures to protect against the inclusion of extraneous material in food.
May 24, 2018Chase Hill FarmUnited StatesFailure to take effective measures to protect against the inclusion of extraneous material in food.
May 16, 2018URCIMARMoroccoFailure to take effective measures to protect against the inclusion of metal and extraneous material in food.
May 10, 2018IMANI IMPORT EXPORT SARL AUMoroccoFailure to take effective measures to protect against the inclusion of metal and extraneous material in food.
Mar 9, 2018E-Z Spuds LLC.United StatesFailure to take effective measures to protect against the inclusion of metal and extraneous material in food.
Mar 8, 2018E. Rojas Enterprises Corp.United StatesFailure to take effective measures to protect against the inclusion of metal in food.
Jan 12, 2018Westfield Farm Inc.United StatesFailure to take effective measures to protect against the inclusion of extraneous material in food.
Dec 6, 2017Michigan Farm Cheese Dairy, Inc.United StatesFailure to take effective measures to protect against the inclusion of extraneous material in food.
Nov 17, 2017Hinsdale & Foster Provisions, LLCUnited StatesFailure to take effective measures to protect against the inclusion of metal and extraneous material in food.
Nov 7, 2017Charlie's Specialties, Inc.United StatesFailure to take effective measures to protect against the inclusion of metal and extraneous material in food.
Sep 21, 2017Wakefield Dairy LLCUnited StatesFailure to take effective measures to protect against the inclusion of metal in food.
Sep 19, 2017Prestige BakeryJamaicaFailure to take effective measures to protect against the inclusion of extraneous material in food.
Sep 1, 2017Working Cow Homemade Inc.United StatesFailure to take effective measures to protect against the inclusion of metal in food.
Aug 25, 2017Bearded Brothers, LLCUnited StatesFailure to take effective measures to protect against the inclusion of metal in food.
Aug 22, 2017Baptista De Almeida Comercio E Industria LtdaBrazilFailure to take effective measures to protect against the inclusion of metal and extraneous material in food.
Aug 22, 2017The Truck Farm, LLCUnited StatesFailure to take effective measures to protect against the inclusion of metal in food.
Aug 17, 2017Tipco Pineapple Company LimitedThailandFailure to take effective measures to protect against the inclusion of metal in food.
Aug 8, 2017Cerreta Candy Company, Inc.United StatesFailure to take effective measures to protect against the inclusion of metal and extraneous material in food.
Jul 7, 2017R&N Inc.United StatesFailure to take effective measures to protect against the inclusion of metal and extraneous material in food.
Jun 30, 2017Greenwood Ice CreamUnited StatesFailure to take effective measures to protect against the inclusion of metal in food.
Jun 19, 2017Atlantic Bakery Ltd.United StatesFailure to take effective measures to protect against the inclusion of metal and extraneous material in food.
Jun 15, 2017Sugar Bakers, Inc.United StatesFailure to take effective measures to protect against the inclusion of extraneous material in food.

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.