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GUIDE TO INSPECTIONS OF MANUFACTURERS OF MISCELLANEOUS FOOD PRODUCTS - VOLUME 1 Note: This document is reference material for investigators and other FDA personnel. The document does not bind FDA, and does no confer any rights, privileges, benefits, or immunities for or on any person(s). This guide is divided into multiple sections. Each section provides specific instructions and information applicable to the individual product or products covered. Prior to conducting any inspection involving any food product manufacturer, review the FD&C Act Chapter IV, Food, 21 CFR 110, GMP's on Food, and the general inspectional instructions in IOM Chapter SECTION 8: VINEGAR, CIDER, APPLE JUICE ESTABLISHMENT INSPECTION In addition to information and instructions provided in IOM Subchapter 530, review Compliance Policy Guide 7109.22 for guidance as to the identity and labeling of various kinds of vinegars. Additionally, reconstituted apple juice, reconstituted cider, and apple juice concentrate are prime candidates for intentional economic adulteration. See Section 10: Orange/Other Juice in this chapter for guidance with respect to juice adulteration. Follow the guidance in that section with respect to possible adulterants in the plant and sample collection for economic adulteration. Direct special attention to the following areas when inspecting these types of food establishments: Unpasteurized apple cider has been associated with outbreaks of food illness caused by pathogenic E. Coli 0157:H7. The apples used to make the cider were believed to have become contaminated with cow manure either from grazing cows in the apple orchard or from the use of cow manure as a fertilizer. Contamination of the apple cider with E. Coli resulted from improperly cleaning of the apples prior to pressing the juice and/or cross contamination from the raw apples to the finished apple cider. Studies on the survival of E. Coli 0157:H7 in unpasteurized apple cider with a pH between 3.6 and 4.0 have shown the organism to be acid tolerant. The use of sodium benzoate 0.1% was shown to reduce the survival rate and have a preservative effect. Raw Materials Determine the firm's specifications for incoming apples. If "drops" are used (apples that have fallen from the tree) what precautions are taken to prevent microbiological contamination of finished product? Inspect incoming apples for evidence of rot and worms. Refer to USDA Publication No. 168, "Market Diseases of Fruit and Vegetables, Apples, Pears, Quinces". Characteristics of bruised vs rotten apples are contrasted as follows:
Conduct field examination as follows:
Manufacturing Process If the firm is manufacturing pasteurized apple juice or pasteurized apple cider, evaluate the firm's pasteurization method and equipment. Pasteurization should be equivalent to heating the product for 30 minutes at 155F or 15 seconds at 180F. You may wish to consult with your regional milk specialist or district LACF expert before inspecting a pasteurized juice product. Follow procedures outlined in Section 7, under Dressings, in evaluating the firm's cleaning procedures for equipment and CIP system. Determine if there are conditions or practices that could result in contamination of the finished product from handling or processing the raw, unwashed apples, i.e., common equipment, switching jobs by employees, cross connections between raw and pasteurized product lines, etc. If the firm is manufacturing unpasteurized apple cider, determine what controls are used and what test are conducted to assure the finished product is not contaminated. If the firm is adding a preservative, review formulation and determine what preservative is being used and at what strength. Check against the Food Additive Status List in the IOM. If unpasteurized apple cider is being produced, collect samples of both the finished product and the raw apples and submit to the servicing laboratory for microbiological analysis. Check for the substitution of colored acetic acid or distilled vinegar for apple cider vinegar or wine vinegar when inspecting vinegar manufacturers. Vinegar generators may become infested with vinegar eels unless steam cleaned frequently. Vinegar eels in bulk vinegar storage tanks prior to filtration are not considered an insanitary condition. However, the presence of vinegar eels in finished bottled vinegar would render the product adulterated. Determine what test are conducted for acidity in the vinegar. The acetic acid concentration should be 4% or higher. SAMPLE COLLECTION Investigational Microbiological If inspectional conditions warrant, collect in-line samples for microbiological examination using aseptic techniques. Refrigerate and ship to the servicing laboratory as soon as possible after collection. In-line subs should be approximately 4 oz. of material per sub. Collect at least 30 units of finished product as part of your in-line sample. Filth (collect separate from microbiological sample) When wormy or rotten whole and cut apples or peels and cores are used and plant conditions are objectionable, collect exhibits and preserve in saturated borax solution containing 0.1% ascorbic acid.
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REPORTING Report the number and percent wormy apples, and then the total number and percent wormy and/or rotten apples, counting each apple only once. Report the results of examination to the firm on the FDA-483 as follows: Source of Sample: _______________ Number of apples examined: ___________________ Wormy Apples (include wormy apples with rot spots). Apples with rot spots: Class 1 - 1/4 to 1/2 in. dia. ________ (#) ________ (%) Class 2 - 1/2 to 1 in. dia. ________ (#) ________ (%) Class 3 - 1 to 1/2 in. dia. ________ (#) ________ (%) Class 4 - over 1/2 apple. ________ (#) ________ (%) Total Total number with rot spots and/or worm (count only once) ________ (#) ________ (%) |
