Inspections, Compliance, Enforcement, and Criminal Investigations
Cherry Point Products Inc.12/7/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New England District
CMS # 381178
VIA UPS OVERNIGHT
December 7, 2012
Mrs. Drusilla Ray, President
Cherry Point Products Inc.
54 Wyman Road
Milbridge, ME 04658
Dear Mrs. Ray
We inspected your seafood processing facility, located at Cherry Point Lane on September 21 to October 17, 2012. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123 & 110). In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products 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). Accordingly, your fish and fishery products are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.
Specific violations observed during the inspection include, but are not limited to, the following:
1. You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (b). However, your firm does not have a HACCP plan for each fish or fishery product with identified hazards including, but not limited to:
Cooked whole whelk and cooked whelk meat to control the food safety hazards including the process-related hazards of pathogenic survival and growth due to time/temperature abuse.
2. You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the critical control points, to comply with 21 CFR 123.6 (a) and (c) (2). A critical control point is defined in 21 CFR 123.3(b) as a "point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels." However, your firm’s HACCP plan for frozen raw vacuum packaged sea cucumber meat does not list the critical control point(s) of finished product labeling for controlling the food safety hazard(s) of C. botulinum toxin formation.
3. You must have a HACCP plan that at a minimum, lists the critical limits that must be met, to comply with 21 CFR 123.6 (c)(3). A critical limit is defined in 21 CFR 123.3(c) as "the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard." Specifically,
a. Your firm’s HACCP plan for shelf stable dried sea cucumber skins lists a cooking critical limit of "(b)(4)°F” at the (b)(4) critical control point, which is not adequate to control pathogenic bacterial survival. Your critical limit lacks an established time for the temperature that has been evaluated and is supported by a scientific study.
b. Your firm’s HACCP plan for shelf stable dried sea cucumber skins does not list a critical limit (s) at the (b)(4) critical control point to control pathogenic bacteria survival through cooking. A critical limit which has been evaluated and supported by a scientific study must be established and implemented.
4. Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plans for shelf stable dried sea cucumber skins and for frozen raw vacuum packaged sea cucumber meat at all the listed critical control points to control hazards including pathogenic bacteria growth and pathogenic bacteria survival through cooking are not appropriate since your corrective actions do not include the corrective action to be taken with the products.
5. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR Part 110, to comply with 21 CFR 123.11(b). However, your firm does not monitor the safety of water; conditions and cleanliness of food contact surfaces; prevention of cross contamination; maintenance of hand-washing, hand-sanitizing and toilet facilities; protection from adulterants; and exclusion of pests as evidenced by;
a) Hoses used for rinsing cooked whelk meat have no backflow prevention.
b) Hoses used for cleaning tables, walls, & floors have no backflow prevention.
c) Hoses supplying water for your main processing area have no effective backflow prevention.
d) Your well along Wyman Road, which supplies water to your facility, had no cover over the well head, leaving the well open.
e) The picking table in the middle of your picking room contains rusted bolt heads & the outer coating has deteriorated in places, leaving the inner fiberglass exposed. This equipment cannot be adequately cleaned or sanitized.
f) The inside of your cooking and cooling tanks have rough welds and the inside of your aluminum picking tables have rough welds. This equipment cannot be adequately cleaned or sanitized.
g) Employees observed in the picking room during the processing of cooked whelk were found to be handling cooked whelk without gloves and with exposed rings.
h) Your black plastic totes used to hold in-process cooked whelk & whelk meat were only being rinsed with water and this is being done on the floor. No washing and sanitizing is being done.
i) In the cooking room, an employee was observed to level off cooked whelk that was being shoveled into black plastic totes with his bare hands. The employee was previously observed touching areas of totes that had been in contact with the floor and had not washed or sanitized.
j) The soap dispensers above the hand washing sinks in your main processing area do not contain soap.
k) Cleanup procedures, including using water with a spray nozzle to clean floors, were occurring in the meat room while cooked whelk was still in uncovered bins prior to being packaged.
l) The arms of the forklift used to lift baskets to the cooker, cooler, and draining screen sat directly on the wet floor when not in use. When the baskets are being lifted into the cooker, cooling bath, and then dumped onto the screen, the arms of the forklift are directly over cooked and uncooked whelk.
m) We observed flaking paint on pipes above and directly behind the uncovered whelk cooking & cooling tanks.
n) We observed numerous flies inside the main processing room.
o) There were visible gaps in the wall of the main processing area where a hose & large pipe exit the building. These gaps were large enough to allow pests to enter the processing facility.
p) We observed pallets, tubs/totes, wood, and other debris stored up against the sides and back walls of the processing facility. These areas can act as harborage areas for rodents and other pests.
q) The bay door leading to the main processing area was observed to be open throughout processing, leaving strip curtains to act as a barrier to pests entering the building. There were large visible gaps between the strips.
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 things you are doing to correct these violations. You should include in your response documentation such as HACCP and verification 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.
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, the seafood HACCP regulation (21 CFR Part 123) 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.
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 re-inspection-related costs. A re-inspection 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. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a domestic facility, FDA will assess and collect fees for re-inspection-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 re-inspection-related costs.
Please send your reply to the Food and Drug Administration, Attention: Scott M. Loughan, Compliance Officer, U.S. Food and Drug Administration, One Montvale Ave., Stoneham, MA 02180. If you have questions regarding any issues in this letter, please contact Mr. Loughan at 802-868-4725 x 109.
Mutahar S. Shamsi
New England District