21 CFR 110.35(b)(1) citations
FDA investigators cited 21 CFR 110.35(b)(1) 344 times at 326 facilities in the inspection citations FDA publishes, most recently in an inspection that ended May 15, 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 year | Citations |
|---|---|
| 2018 | 14 |
| 2017 | 40 |
| 2016 | 31 |
| 2015 | 16 |
| 2014 | 27 |
| 2013 | 30 |
| 2012 | 40 |
| 2011 | 57 |
| 2010 | 57 |
| 2009 | 32 |
Recent citations
The latest inspections that cited this section. Facility names link to each facility's FDA record.
| Inspection ended | Facility | Country | Observation |
|---|---|---|---|
| May 15, 2018 | SPAGEL BROTHERS, INC | United States | Use of cleaning compounds and sanitizing agents which are not safe and adequate under the conditions of use. |
| Apr 20, 2018 | El Nectar LLC T/A Cuba Bakery | United States | Use of cleaning compounds and sanitizing agents which are not safe and adequate under the conditions of use. |
| Apr 11, 2018 | Evo Kitchen, LLC. | United States | Storage or use of toxic materials which are not required to maintain clean and sanitary conditions, are unnecessary for use in laboratory testing procedures, are unnecessary for plant and equipment maintenance, and are… |
| Mar 15, 2018 | Coffee Brothers Inc | United States | Use of cleaning compounds and sanitizing agents which are not safe and adequate under the conditions of use. |
| Mar 12, 2018 | Little Lad's Bakery, Inc. | United States | Use of cleaning compounds and sanitizing agents which are not safe and adequate under the conditions of use. |
| Mar 6, 2018 | Signature Baking Company | United States | Storage or use of toxic materials which are not required to maintain clean and sanitary conditions, are unnecessary for use in laboratory testing procedures, are unnecessary for plant and equipment maintenance, and are… |
| Feb 28, 2018 | Progressive Laboratories, Inc | United States | Use of cleaning compounds and sanitizing agents which are not safe and adequate under the conditions of use. |
| Feb 20, 2018 | R & G Cheese Makers, Inc. | United States | Use of cleaning compounds and sanitizing agents which are not safe and adequate under the conditions of use. |
| Feb 14, 2018 | Tufos To Go LLC | United States | Storage or use of toxic materials which are not required to maintain clean and sanitary conditions, are unnecessary for use in laboratory testing procedures, are unnecessary for plant and equipment maintenance, and are… |
| Jan 9, 2018 | Martins Kitchen LLC | United States | Use of cleaning compounds and sanitizing agents which are not safe and adequate under the conditions of use. |
| Jan 8, 2018 | La Salsa Chilena, Inc. | United States | Storage or use of toxic materials which are not required to maintain clean and sanitary conditions, are unnecessary for use in laboratory testing procedures, are unnecessary for plant and equipment maintenance, and are… |
| Dec 7, 2017 | Leonor Rico | United States | Use of cleaning compounds and sanitizing agents which are not safe and adequate under the conditions of use. |
| Dec 6, 2017 | Michigan Farm Cheese Dairy, Inc. | United States | Use of cleaning compounds and sanitizing agents which are not safe and adequate under the conditions of use. |
| Nov 3, 2017 | New Punjab Sweets Inc. | United States | Storage or use of toxic materials which are not required to maintain clean and sanitary conditions, are unnecessary for use in laboratory testing procedures, are unnecessary for plant and equipment maintenance, and are… |
| Sep 13, 2017 | Turtle Island Foods, Inc. | United States | Use of cleaning compounds and sanitizing agents which are not safe and adequate under the conditions of use. |
| Aug 25, 2017 | Nathan's Soup And Salad Henrietta Inc. | United States | Use of cleaning compounds and sanitizing agents which are not safe and adequate under the conditions of use. |
| Aug 23, 2017 | Heritage Int'l (USA) Inc. | United States | Use of cleaning compounds and sanitizing agents which are not safe and adequate under the conditions of use. |
| Aug 21, 2017 | McDowell Farms Salsa LLC | United States | Use of cleaning compounds and sanitizing agents which are not safe and adequate under the conditions of use. |
| Aug 21, 2017 | Sabatino North America, LLC | United States | Use of cleaning compounds and sanitizing agents which are not safe and adequate under the conditions of use. |
| Aug 8, 2017 | Cerreta Candy Company, Inc. | United States | Use of cleaning compounds and sanitizing agents which are not safe and adequate under the conditions of use. |
| Jul 18, 2017 | Henry Higgins Boiled Bagels LLC | United States | Use of cleaning compounds and sanitizing agents which are not safe and adequate under the conditions of use. |
| Jul 13, 2017 | Lucky Spoon Bakery, LLC | United States | Use of cleaning compounds and sanitizing agents which are not safe and adequate under the conditions of use. |
| Jun 26, 2017 | Mazzeo's Baking Co. | United States | Use of cleaning compounds and sanitizing agents which are not safe and adequate under the conditions of use. |
| Jun 20, 2017 | Wha Ming MN, LLC | United States | Storage or use of toxic materials which are not required to maintain clean and sanitary conditions, are unnecessary for use in laboratory testing procedures, are unnecessary for plant and equipment maintenance, and are… |
| Jun 9, 2017 | 8E's Fine Foods LLC | United States | Storage or use of toxic materials which are not required to maintain clean and sanitary conditions, are unnecessary for use in laboratory testing procedures, are unnecessary for plant and equipment maintenance, and are… |
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