Inspections, Compliance, Enforcement, and Criminal Investigations
Ocean Fresh LLC 12/2/10
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
San Francisco District
- You must implement the record keeping system that you listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(7). However, your firm did not consistently record monitoring observations at the Alum Tanks, Cold Storage Live Sea Urchin and Paper Towel Step or Overflow, and Cold Storage Post Process On Basket, Prepacking Post Packing critical control points to control pathogens listed in your HACCP plan for refrigerated, raw ready-to-eat sea urchin roe. Specifically, you do not have (b)(4) monitoring records for 8/12/10, 7/31/10, 7/16/10, 7/13/10, 6/23/10, 6/2/10, 5/31/10, 5/22/10, 5/18/10, 5/10/10, and 5/5/10. (b)(4) indicated that processing of urchin roe occurred on these dates.
- You must implement the monitoring procedures and frequency that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(4). However, your firm did not follow the monitoring procedure of (b)(4) at a frequency of (b)(4) at Cold Storage Post Process On Basket, Pre Packing Post Packing critical control point to control pathogen growth listed in your HACCP plan for refrigerated, raw, ready-to-eat sea urchin roe. Specifically, on September 9, 2010, during the close-out meeting with FDA, you admitted to our investigator that you did not always monitor critical control point temperatures at the frequencies specified in your HACCP plan for refrigerated, raw, ready-to-eat sea urchin roe.
- Because you chose to include a corrective action plan in your HACCP plan, your described corrective action plans must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plans for refrigerated, raw, ready-to-eat sea urchin roe at the Alum Tanks and Cold Storage Live Sea Urchin & Paper Towel Step or Overflow critical control points to control pathogens are not appropriate. Your corrective action plans do not have provisions to ensure that no product enters commerce that is either injurious to health or is otherwise adulterated as a result of the deviation. For example, you may evaluate the product for time-temperature exposure, destroy the product, or divert it to a non-food use.
- You must maintain sanitation control records that, at a minimum, document monitoring and corrections set out in 21 CFR 123.11(b), to comply with 21 CFR 123.11(c). However, your firm did not maintain sanitation monitoring records for Safety of water that comes into contact with food or food contact surfaces; Condition and cleanliness of food contact surfaces; Prevention of cross-contamination from insanitary objects to food, food packaging material, and other food contact surfaces; Proper labeling, storage, and use of toxic compounds; required for the processing of refrigerated, raw, ready-to-eat sea urchin roe.
- 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 did not monitor Safety of water; Condition and cleanliness of food contact surfaces; and Prevention of cross contamination with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110] as evidenced by:
- None of the (b)(4) hoses at your facility are equipped with backflow prevention devices;
- White perforated plastic totes were being rinsed using harbor water. These plastic totes were used to contain live urchins earlier that day. Seals and birds were observed swimming in the harbor, while boats also unloaded their daily catches at several docks along the harbor.
- Large plastic totes, used for storage and transportation of live urchins, were stacked outside, unprotected, adjacent to the building. Freshly harvested sea urchins were observed being deposited into several of these totes.
- Reusable rubber gloves used in contact with urchins, ready-to-eat urchin roe, and roe processing water were stored in undesignated areas throughout the processing room, including hanging on a rusty metal frame, on top of the plastic salt tote cover, on top of cardboard boxes, inside the hand-washing sink, and on various hooks and wall protrusions around the processing area.
- Our investigator observed that reusable rubber processing gloves were stored in a tattered, visibly soiled Styrofoam, labeled “Clean Gloves” in a hallway that is open to harbor dock on one side and loading dock/parking on other side. Rubber aprons and coveralls were stored hanging in same open hallway, although some were observed brought from home at the beginning of the day.
- Our investigator observed that the tools and equipment used in ready-to-eat urchin roe are not routinely washed or scrubbed before sanitizing:
- On September 1 and 2, 2010, our investigator observed one long yellow hose in the roe packing area uncoiled on two different days, its end outside the curtained door, resting on the concrete ground of the dock. On one occasion, the end of the hose was submerged in a puddle of water on the dock concrete. Seagulls were observed flying around the outside dock area and the outside dock surface was observed being washed down with harbor water. The yellow hose was observed later in cleaning the packing room and water was sprayed on food and non-food contact surfaces.
- An September 2, 2010, our investigator observed an employee, wearing reusable rubber gloves, cracking open sea urchins, then immediately afterwards assisted another employee in cleaning the adjacent floor by picking debris off the floor using the gloves and taking it outside, and then returned to the ready-to-eat urchin processing, unloading the urchins and resumed cracking, without washing and sanitizing his gloves.
- On September 2, 2010, our investigator observed an employee taking two disposable gloves from the box, dropped one on the ground, picked it up, put them on, dipped the gloves in sanitizing solution without washing it, and entered the processing area to begin work. The disposable gloves are used for direct handling of the ready-to-eat urchin roe.
- Ready-to-eat roe processing employees are not routinely washing or sanitizing their disposable or reusable gloves prior to starting/resuming work. The gloves were observed in direct contact with sea urchins and roe on a regular basis.
- On September 1, 2010, our investigator observed four women wearing pierced earrings and two wearing necklaces in the packing area.
- 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 Sea Urchin does not list the critical control point of “Processing” for controlling the food safety hazard of pathogens. A processing critical control point should be added to incorporate time and temperature ratio to include extraction, cleaning, rinsing, alum tank soaking, draining and packaging.