Inspections, Compliance, Enforcement, and Criminal Investigations
Flavors from Florida, Inc. 1/4/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
555 Winderley Place, Suite 200
Maitland, Florida 32751
RETURN RECEIPT REQUESTED
January 4, 2012
Flavors from Florida, Inc.
203 Bartow Municipal Airport
Hwy 17 N
Bartow, FL 33830
Dear Mr. Overholser:
The U.S. Food and Drug Administration (FDA) inspected your juice processing facility, located in Bartow, FL on September 12-16, 2011. The inspection revealed serious violations of the Current Good Manufacturing Practice (CGMP) regulation for food, 21 Code of Federal Regulations (CFR) Part 110. Based on these violations, your diluted juice beverages 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 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 FDA’s regulations through links on FDA’s home page at www.fda.gov.
The significant CGMP violations documented during the inspection were as follows:
1. Your firm does not routinely apply procedures that provide adequate cleaning and sanitizing of equipment. Specifically, your firm stored utensils and equipment parts in a tub of iodine solution with an inadequate concentration of iodine as tested by FDA issued LaMotte testing strips. [21 CFR 110.35(d)(5)].
2. Your firm does not prevent cross contamination from insanitary objects to products and processing equipment as evidenced by the following:
a. On September 13, 2011, an employee returned to the blending platform after going outside to throw away an ingredient bag. He was observed wearing a plastic apron while processing, during the trip outside, and upon his return to continue processing. [21 CFR 110.10(b)(1)]
b. On September 12 and 13, 2011, investigators observed a trash dumpster in the Blending room. On September 13, 2011, the processing of Orange Pulp Wash for your Kosher Orange Puree product took place with this dumpster approximately ten feet away. [21 CFR 110.80(b)(6)].
c. On September 13, 2011, three employees returned from a break without washing their hands before resuming their production activities in violation of 21 CFR 110.10(b)(3). Additionally, two 2 employees dipped their hands into an iodine hand dipping bucket that did not have an adequate concentration of iodine as tested by FDA issued LaMotte testing strips. [21 CFR 110.10(b)(5)].
d. On September 12 and 13, 2011 , employees working with juice products in the Fill and Blending rooms were not wearing hairnets in an effective manner to protect against contamination of the food. [21 CFR 110.10(b)(6)].
3. Your firm does not provide adequate and convenient hand washing facilities furnished with running water in locations where good sanitary practices require employees to wash their hands. Specifically, the fill room, where finished product is packaged, does not have a hand wash station. [21 CFR 110.37(e)]
4. Your firm does not provide for exclusion of pests from your food plant. Specifically, on September 12, 2011, there were two gaps, approximately three feet long by one-half inch wide and one foot long and one-quarter inch wide under the door leading from the warehouse to the outside and the bay door, respectively. Under the door leading from the warehouse to outside, investigators observed what appeared to be five dead insects inside the warehouse. [21 CFR 110.20(7)].
The above violations are not intended to be an all-inclusive list of violations. It is your responsibility to ensure that all of your products are in compliance with the Act and FDA’s regulations. You should take prompt action to correct the violations cited in this letter. Failure to implement lasting corrective action on violations may result in regulatory action without further notice, such as seizure and/or injunction.
You should notify this office in writing within fifteen (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, such as revised HACCP plans, revised sanitation standard operating procedures, recent monitoring records, training records, and revised labeling. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and please include a timetable for the implementation of any remaining corrections.
Please send your reply to the Food and Drug Administration, Attention: Andrea H. Norwood, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, FL 32751. If you have questions regarding any issue in this letter, please contact Ms. Norwood at (407) 475-4724.
Emma R. Singleton
Director, Florida District