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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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S Serra Cheese Company 6/6/13


Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Detroit District
300 River Place
Suite 5900
Detroit, Ml 48207
Telephone: 313-393-8100
FAX: 313-393-8139 


June 6, 2013
Ms. Fina Serra, Co-Owner/Manager
S. Serra Cheese Company
19717 15 Mile Road
Clinton Township,  MI 48035  
Dear Ms. Serra:
The U.S. Food and Drug Administration (FDA) inspected your cheese manufacturing facility located at 19717 15 Mile Road, Clinton Township, MI 48035 on January 8 -23, 2013.  During our inspection, FDA collected environmental samples from multiple areas in your processing facility as well as finished product samples.  FDA laboratory analysis for three finished product samples revealed the presence of excessive levels of non-toxigenic Escherichia coli (E. coli). Furthermore, FDA investigators observed serious violations of the Current Good Manufacturing Practice (CGMP) regulation for food, Title 21, Code of Federal Regulations, Part 110 [21 CFR Part 110].  Collectively, these GMP violations and the noted finished product sample results render ready to eat cheese manufactured by your firm to be adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. §342(a)(4)] in that the products were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health  You can find the Act, the CGMP regulation for foods through links in FDA's home page at www.fda.gov.
Finished product samples were collected and sent to our laboratory for analysis. Laboratory analysis found non-toxigenic E. coli in levels ranging from 23->1100 most probable number (MPN)  per gram per sub in three finished product samples of Sundried tomato cheese, Fresh cherry Mozzarella cheese and Hot Red Pepper Cheese. The presence of non-toxigenic E.coli in dairy products at levels higher than 10 MPN/g in two or more subsamples results as found in these cheese samples, causes the finished products to be adulterated within the meaning of section 402(a)(4) in that your products have been prepared, packed, or held under insanitary conditions whereby products may have become contaminated with filth.
Further, FDA investigators observed serious violations of the Current Good Manufacturing Practice regulation for foods [21 CFR Part 110]. Your significant violations were as follows:
1.    Your plant is not constructed in such a manner as to allow floors to be adequately cleaned and kept clean and kept in good repairfor food manufacturing purposes to comply with 21 CFR 110.20 (b)(4) as evidenced by:
a.    On 01/09/13, standing water in all three areas of the walk-in cooler. Furthermore, the doorway between the two areas of the walk-in cooler, and the grout between floor tiles was observed disintegrated. Carts are routinely pulled through this standing water and over this damaged floor between the walk in cooler and the processing. Ready to eat cheese is placed on these carts and rolled into the walk-in cooler to dry for three days prior to packaging.
b.    On 01/08/13, the floor surface in the main walkway near the cutting/ mixing/ molding machine and the processing table where ricotta cheese is pressed into molds was uneven with large areas of missing sealant. The borders of these areas had rough edges where cheese curd waste and liquid was seeping beneath the sealant.
c.    On 01/09/2013, a hole filled with murky water was observed in the floor near the double tank used for making ricotta cheese. This hole was lined with a PVC pipe that extended approximately eight inches into the floor. Employees’ feet and the wheels of the carts were observed treading through this standing water.
2.    Your firm failed to ensure that manufacturing operations including filling, assembling, packaging, and other operations are performed in such a way that the food is protected against contamination in order to comply with 21 CFR 110.80 (b)(13) (v), as evidenced by:
a.    On 1/8/13, an employee with gloved hands was observed placing a bucket on the floor beneath the pasteurizer valve, then proceeded to fill the bucket with pasteurized milk, added starter culture to the bucket, and then picked up the bucket while his gloved hands came in contact with the bottom of the bucket. The employee then rinsed his gloved hands with only water, and immediately returned to hand press ready to eat pistachio cheese in molds.  
b.    On 1/08/13, an employee were observed to pick up a bucket of whey resting on the floor, touch the bottom of the bucket while transferring whey into the double tank, and then continue to hand pressing pistachio cheese. The employee didn’t change their gloves before touching the ready to eat pistachio cheese.
c.    On 01/10/13, during the packaging of smoked provolone cheese, one employee was observed to touch non-food contact surfaces including door handles and vacuum-packaging machine before picking up ready to eat smoked provolone cheese and touching the inside of the plastic bag.
3.    Your firm failed to conduct cleaning and sanitizing operations for utensils and equipment in a manner that protects against contamination of food, food-contact surfaces, and food-packaging materials as required by 21 CFR 110.35(a). Specifically, during the production of pistachio cheese and ricotta cheese on 01/08/13, one employee sprayed water onto the outside of the pasteurizer that was then observed to aerosolize and reflect directly into a partially uncovered holding tank full of recently pasteurized milk to be used in the processing ready to eat cheese.
4.    Your firm failed to store raw materials in a manner to protect against contamination to comply with 21 CFR 110.80(a)(1). Specifically, (b)(4)lb bags of salt were stored directly under an opened pipe in the ceiling. Liquid droplets and evidence of moisture were observed on the paper salt bags. Salt is used in the processing of all ready to eat cheese products.
5.    Your employees failed to wear suitable outer garments that protect against contamination of food and food contact surfaces to comply with 21 CFR 110.10(b)(1). On 01/08/13 while pressing ready to eat pistachio cheese into molds, employees’ aprons were observed coming into direct contact with the cheese curds. The aprons were soiled, and had many discolorations.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your products and/or enjoin your firm from operating.
This letter is not intended to be an all-inclusive statement of the violations that exist at your firm. You are responsible for ensuring that your firm is operating in compliance with all the requirements of the Act, and the Current Good Manufacturing Practice regulation [21 CFR Part 110]. Your firm should take prompt action to correct the violations addressed in this letter, and additional measures to prevent contamination of your cheeses products   You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Furthermore, we found Listeria innocua, a non-pathogenic microorganism,from six locations within your facility. The presence of Listeria innocua throughout the facility is a further indication of your insanitary practices.
You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
Section 743 of the Act (21 U.S.C. § 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including costs related to re-inspection. A re-inspection is one or more inspections conducted subsequent to an inspection that identified non-compliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees, 21 U.S.C. § 379j-31(a)(2)(B). For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any costs related to re-inspection.
Your firm’s response should be sent to: LCDR Kelli Wilkinson, Compliance Branch, Food and Drug Administration, Detroit District Office. If you have any questions about the contents of this letter, please contact: LCDR Kelli Wilkinson, Compliance Officer, at 313-393-8120.
Glenn T. Bass
District Director
Detroit District Office