Oriental Packing Co., Inc. 3/19/12
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Florida District|
555 Winderley Place, Suite 200
Maitland, Florida 32751
RETURN RECEIPT REQUESTED
March 19, 2012
Herman D. Lue
Oriental Packing Co., Inc.
14855 SW 137th St., Suite 103
Miami, FL 33196
Dear Mr. Lue:
We conducted an inspection of your spice processing facility, located at 14855 SW 137th
Street, Suite 103, Miami, FL 33196 on December 19-20, 22, 2011 and January 4, 2012. During the inspection, the FDA investigators documented serious violations of the Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations (CFR), Part 110 (21 CFR 110). Based on these violations, the ingredients and finished food products manufactured in your facility are adulterated within the meaning of Section 402(a)(4) [21 U.S.C. § 342(a)(4)] of the Federal Food, Drug, and Cosmetic Act (the Act), in that they have been prepared, packed or held under insanitary conditions whereby they may become contaminated with filth, or whereby they may have been rendered injurious to health. You can find the Act and FDA’s regulations through links in FDA's home page at www.fda.gov.
FDA investigators observed the following violations of the CGMP regulation for foods (21 CFR 110):
1. In order to comply with 21 CFR 110.35(d), you must clean and sanitize all food contact surfaces, including storage containers and equipment, in a manner that protects against contamination of food.
Our inspection revealed that your firm failed to clean and sanitize with any routine frequency, shared equipment used to mix all single spice and spice blend products that contain both non-allergenic and allergenic sub-ingredients. Specifically, the investigators observed that interior food-contact surfaces of the large and small product mixers, storage and transport containers used for bulk finished product, and package filling machines are not cleaned nor sanitized between the manufacture of products containing the allergen wheat and products that do not contain the allergen wheat as evidenced by:
- An employee deposited Fish Seasoning from the mixer into a plastic (b)(4) gallon container that had previously been filled with (b)(4) Seasoning. The container was not cleaned prior to filling with Fish Seasoning.
- An accumulation of spice residue was observed on interior food contact surfaces of the blades and kettle of the small mixer, which was covered and ready for next use.
- Containers used to hold different products that contain wheat are also used without subsequent cleaning or sanitizing for products that do not contain wheat..
2. In order to comply with 21 CFR 110.80, all reasonable precautions must be taken to ensure that production procedures do not contribute to contamination from any source. Therefore, equipment, containers and utensils used to convey, hold, and store food shall be constructed, handled, and maintained during manufacturing or storage in a manner that protects against contamination.
Our inspection revealed that your firm processes a variety of blended spice products on equipment that has not been adequately cleaned and sanitized and stores food product, raw materials, and packaging materials, in a manner that does not protect against contamination, as evidenced by:
- On the bottom of the large mixer, there is a plastic chute that is damaged and separating from the equipment and was attached to the mixer using adhesive tape, that exhibits an accumulation of spice residue.
- Raw ingredients were stored in open bags that were not sealed closed to protect against contamination.
- Plastic lids used for packaging were stored open and uncovered, directly against a wall on the floor of the packaging area.
3. In order to comply with 21 CFR 110.35(c), no pests are allowed in any area of a food plant. Furthermore, effective measures must be taken to exclude pests from the processing areas and to protect against the contamination of food on the premises by pests. However, our investigators observed the following evidence of a lack of adequate pest control:
- One dead roach was located on the floor under the raw material weighing and preparation table in the mixing room loft.
- An unscreened loading bay door in the receiving open was left open when loading and/or unloading activities were not being conducted.
Your product Blue Mountain Country Jamaican Curry Powder fails to bear a nutrition facts panel on the product label as required by 21 CFR 101.9. However, per 21 CFR 101.9(j)(4) a food containing insignificant amounts of all nutrients is exempt from nutrition labeling requirements. If the product is determined to contain insignificant amounts of all nutrients, it is exempt from nutrition labeling requirements.
The serving size declaration for the “Grace Fish Seasoning” product is not based on the reference amount customarily consumed (RACC) established for this specific type of product, as required by 21 CFR 101.12(b). Specifically, the label declares a serving size as “1/2 TSP. (1g)”, however the RACC established for “Salt, salt substitutes, seasoning salts (e.g., garlic salt)” is “1/4 tsp”.
The ingredient statement for the “Jamaican Choice Flavor Enhancer” product indicates that the product is solely comprised of “monosodium glutamate (MSG)”. Per 21 CFR 101.22(h)(5), any monosodium glutamate used as an ingredient in in food shall be declared by its common or usual name, “monosodium glutamate”. Therefore, the use of the term “flavor enhancer” in the product name is not an appropriately descriptive term.
We acknowledge receipt of your firm's response letter dated January 10, 2012 to the FDA-483, Inspectional Observations, issued to you at the close of the inspection. However, we were unable to properly evaluate your response since you did not provide any documentation of your implemented corrections. In addition, you did not indicate when each correction was implemented, or how you will improve monitoring of these conditions to prevent future violations.
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.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. You should include documentation of the corrective actions you have taken. 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.
This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and the Current Good Manufacturing Practice regulation (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 the U.S. Food and Drug Administration, Attention: Angela E. Glenn, Acting Compliance Officer, 555 Winderley Place, Suite 200, Maitland, FL 32751. If you have any questions regarding any issues in this letter, please contact Ms. Glenn by telephone at (407) 475-4724.
Emma R. Singleton
Director, Florida District