Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Cincinnati District Office
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2761
February 12, 2014
Via United Parcel Service
John Wilcha, Chairman
Bluegrass Holdco, Inc.
2187 Atlantic St.
Stamford, CT 06902
Dear Mr. Wilcha:
The U.S. Food and Drug Administration (FDA) conducted inspections on August 20 and 21, 2013 and September 16-18, 23, and 25, 2013 of your whey powder manufacturing facility, Bluegrass Dairy and Food, Inc., located at 1117 Cleveland Ave., Glasgow, KY. FDA investigators performed environmental sampling which identified the presence of Salmonella in your facility. Based on the finding of Salmonella, we have determined that the food products you process in your whey powder manufacturing facility 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)] in that they were prepared, packed or held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health. You may find the Act and FDA’s regulations through links on FDA’s homepage at www.fda.gov.
Salmonella is a pathogenic organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy individuals may suffer short-term symptoms such as severe diarrhea, bloody diarrhea, fever, chills, abdominal discomfort, and occasionally vomiting.
During the inspection, FDA collected environmental samples from various locations within your firm’s facility. Laboratory analysis of these environmental samples found Salmonella in four separate subsamples collected from processing locations where food is likely to be exposed. These locations were in your (b)(4) manufacturing room. Positive samples were taken from the control panel box next to the bagging room door, the wall and ridge next to the (b)(4) entry door, the base support of your rotary dryer, and the liquefier control panel.
This was not the first time FDA investigators collected environmental samples from your facility that were found to be positive for Salmonella. FDA investigators collected positive environmental samples during an inspection on January 29 and 30, 2013 as well. Analysis using Pulsed-Field Gel Electrophoresis (PFGE) showed that Salmonella isolates obtained from the FDA environmental samples collected during the January 2013 inspection were indistinguishable by both a primary and secondary enzyme with isolates obtained during the August 2013 inspection. When a PFGE pattern of an isolate is indistinguishable from the pattern of another isolate from a common source, it is highly likely that two isolates are the same strain of Salmonella---in this case Salmonella senftenberg. These PFGE results suggest that Salmonella senftenberg may have been present throughout different periods of time at your facility and may have become established in a niche environment in your facility. This may also suggest that any new sanitation procedures you adopted after the discovery of Salmonella in January 2013 were inadequate to remove this pathogenic organism, and that you must take additional corrective measures. Further, finding Salmonella in locations where food is exposed indicates a high risk of product contamination. Based on our analytical and inspection findings, we determined that the products made at your firm’s whey powder manufacturing facility are adulterated within the meaning of Section 402(a)(4) of the Act, in that they were prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth or may have been rendered injurious to health.
Appropriate control of Salmonella in a food processing environment requires expert knowledge of the unique characteristics of the organism. It is essential to identify the areas of the food processing plant where this organism is able to grow and survive (niche areas) and to take such corrective actions as necessary to eradicate the organism by rendering these areas unable to support the growth and survival of the organism.
We received a written response from Mr. Billy Joe Williams, CEO, Bluegrass Dairy and Food, Inc. on October 17, 2013, addressing the positive environmental samples that FDA reported to this firm on September 11, 2013 via telephone and email. The response states that the firm has shut down the (b)(4) and is thoroughly cleaning it and the room where it is located. It also states that the firm has hired a third-party consultant to investigate the contamination problem and recommend corrective actions to prevent microbial contamination. However, the response lacks further detail regarding what specific corrective actions your firm has taken or will take, and why these corrective actions are appropriate. The adequacy of your corrective actions, along with the implementation of these corrections, will be verified during our next inspection.
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 applicable regulations. We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.
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 reinspection related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees [21 U.S.C. § 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct these violations. You should include in your response, documentation such as environmental and product testing results for microorganisms, sanitation records, 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.
Your written response should be sent to Mark E. Parmon, Compliance Officer, U.S. Food and Drug Administration, 6751 Steger Drive, Cincinnati, OH 45237. If you have any questions about this letter, please contact Compliance Officer Parmon at (513) 679-2700, Ext. 2162, or email@example.com.
Paul J. Teitell
Cc: Mr. Billy Joe Williams, CEO
Bluegrass Dairy and Food, Inc.
1117 Cleveland Ave.
Glasgow, KY 42141-1011