Inspections, Compliance, Enforcement, and Criminal Investigations
Terra Verde Farm Inc 16-Sep-02
Department of Health and Human Services
Public Health Service
Atlanta District Office
September 16, 2002
VIA FEDERAL EXPRESS
Franco R. Boeri, President
Terra Verde Farm, Inc.
4851 Ga. Hwy. 85, Building 2, Unit 201
Forest Park, GA 30297
Dear Mr. Boeri:
On August 5 & 6, 2002, the Food and Drug Administration (FDA) conducted an inspection of your food warehouse located at Forest Park Georgia. During that inspection, our investigators documented numerous insanitary conditions which were included Form FDA 483, Inspectional Observations, issued to, and discussed with you at the conclusion of the inspection. In addition, our investigators collected samples of various food products and/or rodent/insect filth found throughout your warehouse, which upon analyses by our laboratory constitute laboratory confirmation of our investigators' findings.
The insanitary, conditions observed at your firm during our inspection cause the food products stored and distributed by you, to be adulterated within the meaning of Section 402(a)4 of the Federal Food Drug, and Cosmetic Act(the Act). They are adulterated because they have been held under conditions whereby they, may have become contaminated with rodent/insect filth. In addition, insanitary conditions documented within the food products render these products adulterated under Section 402(a)(3) of the Act. They are adulterated under this section of the Act in that they consist in whole or in part of filthy substances, namely insect filth.
Specifically, the inspection disclosed the following insanitary conditions:
. Two (2) dead mice and rodent excreta pellets were observed in a box containing spices located in the north-central area of the warehouse. [21 CFR l10.35(c)]
. Numerous rodent excreta pellets were observed on the floor near stored food products and on top of food packages throughout the warehouse. [21 CFR 110.35(c)].
. Evidence of live insect infestation observed throughout the warehouse floor and on top of food packages. [21 CFR 110.35(c)].
. Seven different lots of food products, including wheat flour, corn meal, and bread, were observed by our investigators to be the affected by an active live-insect infestation. Our laboratory identified some of these insects as grain beetles (Oryraephilus species). [21 CFR 110.35(c) and 21 CFR 110.80(b)(9)]
Building and Grounds
. Our investigators observed numerous openings along the west and east walls of your warehouse, through which rodents and insects can gain access into the building. For example, there were: (1) openings under the west and east doors, each approximately 1" high by 37" wide, leading to the outside of the building; (2) large gaps at the sides and bottoms of all loading doors; and, (3) a large opening, approximate 3" by 3" at the southwest corner of the building that, although covered with a screen mesh, cannot prevent entry of insects to the building. [21 CFR 110.20(b)(7)]
. Piles of trash, debris, and non-food items were observed throughout the warehouse, which can provide rodents with harborage. [21 CFR 110.37(f)]
. An opened dumpster outside the building containing garbage and insects was located within 10 feet of an opened warehouse door. [21 CFR 110.20(a)(4)]
. Spilled food was observed inside the warehouse and outside the warehouse doors, which were opened at the time. [21 CFR 110.37(f)]
. Condensation from the cooler's ceiling was observed dripping onto food products including parmesan cheese and lettuce. [21 CFR 110.20(b)(4)]
. Temperatures in the west side and east side of the cooler were 57.2°F and 50.9°F respectively. The cooler was not fitted with any indicating thermometer or temperature recording device. [21 CFR 110.80(b)(3) and 21 CFR 110.40(e)]
. Several food products were stored on the floor, against the walls, and/or on dirty wood pushcarts. [21 CFR 110.93]
Other Insanitarv Practices
. Granular rodenticide was observed on the floor within three feet of food products, which were also stored directly on the floor. [21 CFR 110.35(c)]
Our lab confirmed rodent and insect evidence collected from various products and storage areas in your warehouse. You may have received or will receive various letters from our laboratory addressing our analytical findings.
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.
Please respond in writing within three (3) weeks from your receipt of this letter. Your response should outline the specific things you are doing to correct and prevent the recurrence of these violations. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining violations.
This letter may not list all the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, and the Good Manufacturing Practice regulations (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Please send your reply to Carlos A. Bonnin, Compliance Officer, U.S. Food and Drug Administration, 60 Eighth Street, N.E., Atlanta, Georgia 30309. If you have questions regarding any issue in this letter, please contact Mr. Bonnin at 404-253-1277.
Barbara A. Wood, Acting Director