This diary is meant to serve as one small example of how our government works each and every day to protect us. I'm so sick of the current meme that regulating corporations is killing our economy, and that government needs to "get out of the way" of the job creators. Here's a corporation, located in Poplar Grove, Ill., that clearly needs to be regulated. All text in blockquotes is from a warning letter recently published on the FDA website, fda.gov.
Warning: some descriptions of the conditions at this plant may make you ill.
Our inspection of your facility revealed the following cGMP deviations:
1. You do not use water which is safe and of adequate sanitary quality in food and food-contact surfaces, to comply with 21 CFR 110.37(a) , which specifies that running water at a suitable temperature, and under pressure as needed, shall be provided in all areas where required for the processing of food, for the cleaning of equipment, utensils, and food-packaging materials, or for employee sanitary facilities. During the inspection, our investigators documented the following:
* Un-tested well water is used to manufacture finished food products.
* Hot water was not available during the inspection.
2. You do not have plumbing adequately installed and maintained to properly convey sewage and liquid disposable waste from the plant to comply with 21 CFR 110.37(b)(2). Specifically, on 11/2/201, a sump pump was observed pumping water through a black corrugated sump hose to an open sewer pipe. Sewage was observed spraying out of the hose along its entire length and spraying throughout the production room.
3. Your facility’s plumbing constitutes a source of contamination to food, water supplies, equipment, and utensils and therefore does not comply with 21 CFR 110.37(b)(3). Specifically, four faucets were observed mounted on poles with a hose attached that were not protected with any backflow prevention device in production area of the facility where Ready-To-Eat (RTE) food products are manufactured. The faucets for supplying water to each of the kettles are installed below the flood level rim.
4. Your facility’s plumbing is not adequately installed and maintained to properly convey sewage and liquid disposable waste from the plant to comply with 21 CFR 110.37(b)(2) The production hose used to transfer drainage and waste materials from the open drainage pit in the center of the room to the open floor drain in the cherry processing room is connected directly to the sewer line. During the inspection, the hose was leaking and spraying waste water and other materials across the cherry processing room floor.
5. Your facility’s plumbing is not adequately installed and maintained to provide adequate floor drainage to comply with 21 CFR 110.37(b)(4). Specifically, on 11/2/2010 three separate sump pits located in the production room were not draining and pooling sewage was observed in and around each of the sump pits. The concrete floor around all the drains throughout the facility is damaged, which allows sewage to pond on the floors in all production areas.
6. You do not provide employees with readily accessible and adequate toilet facilities to comply with 21 CFR 110.37(d). Specifically, the toilet facilities are inadequate and are only usable by employees when management turns the water on to that location. Moreover, the toilet facilities were not maintained in a sanitary condition to comply with 21 CFR 110.37(d)(1). The bathroom sink was soiled with iron deposit, mold and grime.
7. You do not keep toilet facilities in good repair to comply with 21 CFR 110.37(d)(2). There is only one functional toilet located in the facility. The one functional toilet does not have a functional flush lever.
8. You have toilet doors open into areas where food is exposed to airborne contamination, and there are no alternative means taken to prevent such contamination, which is a violation of 21 CFR 110.37(d)(4). Specifically, there are no outer doors for the bathroom facility and the two individual toilet room doors were both open and exposed to the coconut processing area.
9. You do not provide hand washing and hand sanitizing facilities at each location in the plant where needed to comply with 21 CFR 110.37(e)(1). Our investigators observed the following:
* There were no hand washing or sanitizing facilities in the cherry production or cherry picking rooms where maraschino cherries are manufactured.
* No operational hand washing facilities were available in the coconut processing room where ready to eat food products are handled by employees.
10. Your hand-washing facilities do not comply with 21 CFR 110.37(e), which requires hand-washing facilities to be convenient and be furnished with running water at a suitable temperature. Specifically, our investigators noted the following:
* There were no hand-washing sinks located in any production areas, including the cherry processing room, picking room, and coconut processing room.
* There was no running water available at the hand washing facility or at the shipping room sink for employees to have access to wash their hands.
* The hose located in the coconut processing room, which was observed being used by one employee to rinse off his hands after packaging (b)(4) was only capable of delivering cold water.
These are only the first 10 out of 30 observations listed in the warning letter. I'm thrilled that my tax dollars pay for inspections and enforcement actions like this - and I can't fathom the mindset that believes the "free market" is a better protector.
9:08 AM PT: Link to this warning letter: http://www.fda.gov/...