Inspections, Compliance, Enforcement, and Criminal Investigations
Koon Cheong Lung 11/27/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
College Park, MD 20740
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 your ready-to-eat oyster sauce to control the food safety hazard of pathogen growth and toxin formation, including Clostridium botulinum, in your finished product.
2. 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 the water that comes into contact with food or food contact surfaces; the cleanliness of food contact surfaces; prevention of cross-contamination from insanitary objects; maintenance of hand washing, hand sanitizing, and toilet facilities; protection of food, food packaging material, and food contact surfaces from adulteration; proper labeling, storage and use of toxic chemical; control of employee health conditions; and exclusion of pests as required for the processing of your ready-to-eat oyster sauce. During our inspection it was revealed that your firm does not have any formal monitoring or recording practices related to sanitation control.
3. Your firm failed to take all reasonable precautions to ensure production procedures do not contribute to contamination from any source in accordance with 21 CFR 110.80. For example:
- Raw materials used to manufacture oyster sauce were placed directly on the wet floor. Additionally, a bucket of starch was placed on an opened bag of salt. The dirty bottom of the bucket was in direct contact with the salt.
- An employee was observed using a rubber water hose that had been placed directly on the wet floor to add water into the steam kettle. Water is one of the ingredients of the oyster sauce being manufactured. The tip of the water hose was in contact with the product inside the steam kettle.
- An employee was observed (b)(4) used in the product with bare hands and arms.
4. Your plant and facilities must be constructed in such a manner that drip or condensate from fixtures, ducts, and pipes does not contaminate food, food-contact-surfaces or food packaging materials to comply with 21 CFR 110.20(b)(4). Specifically, our investigator observed the following:
- Condensate from the ceiling dripping into the open steam kettle where oyster sauce was being manufactured.
- Condensate dripping onto open bags of raw materials such as salt, sugar, starch mixture.
- Water leaking from ceiling in several areas, including the back area of the raw material storage and near the entrance of the production room.
5. Your equipment and utensils must be designed and be of such material and workmanship as to be adequately cleanable and shall be properly maintained, as required by 21 CFR 110.40(a). However, your equipment and utensils were not cleaned appropriately. Specifically, layers of grease-like substance or product residue were observed on the following equipment:
- Rotors and outside of the steam kettles
- Plastic bucket used to hold raw materials
- Conveyer for glass bottles and finished products
- Product filling heads
6. You failed to provide, where necessary, adequate screening or other protection against pests to comply with 21 CFR 110.20(b)(7). Specifically, the window in the production room was open without a screen and the investigator observed several flying insects.
7. Your firm failed to provide food handlers appropriate training in proper food handling techniques and food-protection principles to provide a level of competency necessary for production of clean and safe food to comply with 21 CFR 110.10(c). Specifically, you informed our investigator that your employees have not received any formal training in current good manufacturing practices.
8. Your firm did not assign responsibility for assuring compliance with current good manufacturing practices relating to personnel to competent supervisory personnel, as required by 21 CFR 110.10(d). Specifically, your general manager informed our investigator that no one at the firm is aware of or has knowledge of current good manufacturing practices.
9. Your firm failed to provide safety-type lighting fixtures over exposed food to comply with 21 CFR 110.20(b)(5). Specifically, our investigator observed light fixtures in the production room above or near the open steam kettle where oyster sauce was being manufactured were not covered.
10. Your firm’s hand-washing facilities were not adequate to comply with 21 CFR 110.37(e). Specifically, our investigator observed the following:
- The toilet facilities did not have hand-washing soap, hot water, sanitary towel service or suitable drying devices.
- The toilet facilities did not have a sign to instruct employees to wash and, where appropriate, sanitize their hands before they start work, after each absence from post of duty, after using the toilet, and when their hands may have become soiled or contaminated. These signs must be posted in the processing room and restrooms.