DEPARTMENT OF HEALTH & HUMAN SERVICES
March 21, 2012
VIA OVERNIGHT DELIVERY
Ms. Julie Cameron
106 Cameron Rd,
Meredith, VIC 3333,
Reference No.: 288377
Dear Ms. Cameron:
We inspected your soft cheese manufacturing facility, Meredith Dairy, located at 106 Cameron Rd, Meredith, VIC 3333, Australia, on November 7 and 8, 2011. During that inspection, we found that you had violations of the current Good Manufacturing Practice (cGMP) regulations for food manufacturers as described in Title 21, Code of Federal Regulations, Part 110. Accordingly, your cheese products are adulterated, in that they have been 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 may find the Act and the cGMP regulations through links in FDA’s home page at www.fda.gov.
That inspection resulted in FDA’s issuance of an FDA-483, Inspectional Observations, listing the deviations found at your firm at the conclusion of the inspection. Our records indicate that your firm has not yet responded.
We note the following deviations from the requirements of the current Good Manufacturing Practice regulation:
You must take all reasonable precautions to ensure that your production procedures do not contribute to contamination from any source in order to comply with 21 CFR 110.80. Our investigator observed employees packing ready to eat cheese into finished product containers with their bare hands. In addition, you use your bare hands to transfer minced garlic used in the cheese to plastic tubs.
You must have take effective measures to protect against the inclusion of metal in food to comply with 21 CFR 110.80(b)(8). However, the investigator observed metal blades inside fermentation tanks being used in the cheese making as well in the cheese salt mixer, but no metal detector was observed being used on finished products.
You must ensure that plumbing does not constitute a source of contamination to the food to comply with 21 CFR 110.37(b)(3). However, the investigator observed that hose connections in the production room did not have backflow prevention devices.
This letter may not list all the violations at your facility. You are responsible for ensuring that your firm operates in compliance with the Act and the current Good Manufacturing Practices regulations (21 CFR Parts 110). You also have a responsibility to use procedures to prevent further violations of the Federal Food, Drug, and Cosmetic Act and all applicable regulations.
You should respond in writing within thirty (30) 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 that would assist us in evaluating your corrections. If you cannot complete all corrections within thirty (30) days you should explain the reason for your delay and state when you will correct any remaining violations.
Please send your reply to the U. S. Food and Drug Administration, Attention: Carol D’lima, Office of Compliance, Division of Enforcement, Food Assessment Adulteration Branch (HFS-607), 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. If you have any questions regarding any issue in this letter, you may contact Ms. D’lima at (240) 402-2033 or via email at Carol.Dlima@fda.hhs.gov.
Jennifer A. Thomas
Division of Enforcement
Office of Compliance
Center for Food Safety
and Applied Nutrition