Inspections, Compliance, Enforcement, and Criminal Investigations
Zarda Foods LLC 7/31/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Kansas City District
Telephone: (913) 752-2100
July 31, 2012
RETURN RECEIPT REQUESTED
Ref. KAN 2012-12
Terry L. Hyer, COO
Zarda Foods, LLC
621 SE Central Drive
Blue Springs. Missouri 64014
Dear Mr. Hyer:
The Food and Drug Administration (FDA) inspected your processing facility, located at 621 S.E. Central Drive, Blue Springs, Missouri on July 17-18, 2012. Our investigator documented serious violations of the Current Good Manufacturing Practice regulation, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110).
Based on your failure to comply with the requirements of the Current Good Manufacturing Practice (CGMP) regulation in 21 CFR Part 110, we have determined that your food products are 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)). You may find the Act and the CGMP regulations through links on FDA's home page at www.fda.gov.
The inspector's observations were presented to you on an FDA-483 at the conclusion of the inspection on July 18, 2012. The significant violations documented during the inspection include the following:
1. You failed to manufacture food products. including packaging and storage, under such conditions and controls as are necessary to minimize the potential for the contamination of food, as required by 21 CFR 110.80(b)(2). One way to comply with this requirement is careful monitoring of physical factors such as time, temperature, humidity, water activity, pH, pressure, flow rate, and manufacturing operations such as freezing, dehydration, heat processing, acidification, and refrigeration to ensure that mechanical breakdowns, time delays, temperature fluctuations, and other factors do not contribute to the decomposition or contamination of food.
Refrigerated foods must be held at 45 degrees Fahrenheit or below as appropriate for the particular food involved.
• For instance, at approximately (b)(4) AM, on (b)(4), you packaged Zarda Original Baked Beans/3 pounds container (lot# (b)(4). At approximately 12:16 PM, on July 17, 2012, our investigator observed the same lot of product stored in your walk-in cooler. Our investigator measured the internal temperature of this product located in the walk-in cooler and revealed (b)(4) degrees Fahrenheit.
On July 18, 2012, our investigator observed the same lot of product (lot#(b)(4) your walk-in freezer. Later that day, at approximately 12:00 PM our investigator measured the internal temperature of this product located in the walk-in freezer and found (b)(4) degrees Fahrenheit. After packaging, this product was held for more than (b)(4) hours at a temperature range of (b)(4) to (b)(4) degrees Fahrenheit and within this (b)(4) hour period the product never reached the required refrigeration temperature.
• For instance, on (b)(4) at approximately (b)(4) AM, you packaged Zarda KC Classic Baked Beans/3 pounds container (lot#(b)(4). On July 17, 2012, our investigator observed the same lot of product (lot#(b)(4) stored in your walk-in cooler. On July 17, 2012, at approximately 12:28 PM, our investigator measured the internal temperature of this product located in your walk-in cooler and revealed (b)(4) degrees Fahrenheit. This product was held for more than (b)(4) hours without ever reaching the required refrigeration temperature.
2. You failed to use a sanitizing agent adequately, as required by 21 CFR 110.35(d)(5). Specifically, you did not follow instructions for the sanitizing agent utilized on your food contact surfaces intended for manufacturing baked bean products.
We reviewed your written response addressing this deviation, which included proposed corrective actions related to the use of the sanitizing agent. A follow-up inspection will be required to assure these corrective actions have been adequately implemented.
The above violations are not intended to be an all-inclusive list of violations in your plant. You are responsible for ensuring that all your manufacture products are in compliance with the Act and all of its implementing regulations, including the CGMP regulations (21 CFR Part 110). You are also responsible for using procedures to prevent further violations of the Act, all applicable regulations, and all other requirements of federal law.
You should take prompt action to correct the violations cited in this letter. Failure to implement lasting corrective action of violations may result in regulatory action being initiated by FDA without further notice. For example, we may seize your products and/or enjoin your firm from operating.
You should notify this office in writing within 15 working days from your receipt of this letter of the current status of your corrective actions and the specific steps you have taken to correct the noted violations. In your response, include documentation of your corrective actions or steps towards long-term, corrective action. If you cannot complete all corrections before you respond, you should explain the reason for the delay and include a timetable for the implementation of any remaining corrections.
If you have any questions regarding any issue in this letter, please contact Tamara Umscheid, Compliance Officer at 913-752-2434.
John W. Thorsky
Kansas City District Director