21 CFR 110.80(b)(2) citations

Manufacturing conditions

FDA investigators cited 21 CFR 110.80(b)(2) 1,504 times at 1,312 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Jan 8, 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 year	Citations
2020	1
2019	4
2018	58
2017	153
2016	134
2015	142
2014	141
2013	132
2012	192
2011	226

Recent citations

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

Inspection ended	Facility	Country	Observation
Jan 8, 2020	ASK Foods LLC.	United States	Failure to manufacture foods under conditions and controls necessary to minimize contamination.
Sep 20, 2019	Superior Ice Company	United States	Failure to store foods under conditions and controls necessary to minimize the potential for growth of microorganisms and contamination.
Jul 2, 2019	Basic American, Inc	United States	Failure to manufacture foods under conditions and controls necessary to minimize contamination.
Apr 3, 2019	Cali Rice Valley Inc.	United States	Failure to manufacture and store foods under conditions and controls necessary to minimize the potential for growth of microorganisms and contamination.
Jan 22, 2019	Pachranga Foods	India	Failure to manufacture and package foods under conditions and controls necessary to minimize the potential for growth of microorganisms and contamination.
Sep 21, 2018	Seong Hoon Kim	United States	Failure to manufacture foods under conditions and controls necessary to minimize contamination.
Aug 27, 2018	Galaxy International Limited Partnership	India	Failure to package and store foods under conditions and controls necessary to minimize contamination.
Aug 23, 2018	Gulfstream Tomato Growers, Ltd	United States	Failure to store foods under conditions and controls necessary to minimize the potential for growth of microorganisms and contamination.
Aug 23, 2018	Hialeah Tomatoes & Fresh Produce, Inc.	United States	Failure to store foods under conditions and controls necessary to minimize the potential for growth of microorganisms and contamination.
Aug 17, 2018	Tan Tan Tofu	United States	Failure to manufacture foods under conditions and controls necessary to minimize the potential for growth of microorganisms and contamination.
Aug 7, 2018	USM Manufacturing, LLC-	United States	Failure to manufacture foods under conditions and controls necessary to minimize the potential for growth of microorganisms and contamination.
Aug 6, 2018	Ambros Tinong's Bakery	United States	Failure to manufacture, package and store foods under conditions and controls necessary to minimize the potential for growth of microorganisms and contamination.
Aug 6, 2018	Juices International, Inc.	United States	Failure to manufacture, package and store foods under conditions and controls necessary to minimize the potential for growth of microorganisms and contamination.
Jul 31, 2018	MATILDA GROUP INC.	United States	Failure to manufacture foods under conditions and controls necessary to minimize contamination.
Jul 20, 2018	NARA One Food LLC	United States	Failure to manufacture foods under conditions and controls necessary to minimize contamination.
Jul 20, 2018	Tougias Baking Company, Inc.	United States	Failure to manufacture foods under conditions and controls necessary to minimize contamination.
Jul 6, 2018	Florida Smoked Fish, LLC	United States	Failure to manufacture foods under conditions and controls necessary to minimize contamination.
Jul 2, 2018	Robert Pulido SR. Investments, Inc	United States	Failure to store foods under conditions and controls necessary to minimize contamination.
Jun 27, 2018	Streetpops Inc	United States	Failure to manufacture foods under conditions and controls necessary to minimize contamination.
Jun 15, 2018	BROLEM COMPANY S.A.C.	Peru	Failure to manufacture foods under conditions and controls necessary to minimize contamination.
Jun 13, 2018	Salinas, Inc.	United States	Failure to store foods under conditions and controls necessary to minimize contamination.
Jun 5, 2018	Country Crust LLC	United States	Failure to manufacture foods under conditions and controls necessary to minimize the potential for growth of microorganisms and contamination.
May 25, 2018	Russian Chocolate, Inc.	United States	Failure to manufacture, package and store foods under conditions and controls necessary to minimize contamination.
May 24, 2018	5 Spoke Creamery, LLC	United States	Failure to manufacture, package and store foods under conditions and controls necessary to minimize the potential for growth of microorganisms and contamination.
May 23, 2018	K AND B CO., Inc	United States	Failure to manufacture and package foods under conditions and controls necessary to minimize the potential for growth of microorganisms and contamination.

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