Pt. Bitung Mina Utama 10/31/11
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD 20740
Case I.D. #228235
VIA EXPRESS MAIL
OCT 31 2011
Mr. Chen Yung Shiu, Commissioner Green Globe Corporation
P.T. Bitung Mina Utama
8-2F, No. 380 Min Chuan 2nd
Taiwan, Republic of China
Dear Mr. Chen,
The U.S. Food and Drug Administration inspected your seafood processing facility, Pt. Bitung Mina Utama, located at Jl Aertembaga 2 Lingkungan 2, Kec. Aertembaga, Bitung, North Sulawesi 95526 Indonesia on June 2 – 4, 2011. During that inspection, we found that you had deviations from the Seafood Hazard Analysis and Critical Control Point (HACCP) Regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). That inspection resulted in FDA’s issuance of an FDA-483, Inspectional Observations, listing the deviations found at your firm at the conclusion of the inspection. We acknowledge receipt of your response to the 483, which was sent via email on June 20, 2011. That email contained several documents including a revised HACCP plan as well as supporting documentation. We have reviewed that plan and have addressed our concerns with the response below.
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 frozen vacuum packaged raw tuna is adulterated, in that it has 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 and Controls Guidance: 4th
Edition (the Hazard Guide) through links in FDA’s home page at www.fda.gov
We note the following serious deviations:
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 have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6 (a) and (c) (1). A food safety hazard is defined in 21 CFR 123.3 (f) as "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption. However, your firm’s revised HACCP plan provided in your response dated June 20, 2011 for tuna (but which does not explicitly identify any specific fish product), does not identify the food safety hazards of pathogen growth and toxin formation, including Clostridium botulinum growth and toxin formation; and undeclared allergens associated with finfish species.
With regard to the hazard of Clostridium botulinum, we note that your revised plan sent with your June 20th response includes a “Chilling Room” critical control point. This appears to be intended as your carbon monoxide (CO) treatment. Because the CO treatment is conducted under reduced oxygen conditions (b)(4) this step introduces the hazard of Clostridium botulinum growth and toxin formation. Consequently, once the hazard of Clostridium botulinum is identified, FDA recommends establishing a critical limit of 3.3°C (38ºF) or below, rather than the current critical limit listed as (b)(4) during this treatment period.
We acknowledge that you have installed a temperature recorder at this “Chilling” Room critical control point and that your revised HACCP plan includes reference to an automatic recording machine at the “Chilling Room” critical control point, (b)(4). It is unclear whether this equipment is capable of continuously monitoring and recording time and temperatures. FDA recommends continuous monitoring in conjunction with a visual check of the data from the device at least once a day.
We also note that your finished products are vacuum packed and frozen and that your revised plan includes a “Packing/Labeling” critical control point for monitoring the “Keep Frozen” statement. However, FDA recommends each individual package also instruct end-users to “Keep Frozen, thaw under refrigeration immediately prior to use” to control the hazard of Clostridium botulinum. In addition, we suggest that your firm monitor each batch of labels to ensure that the species of fish is appropriately identified to control the hazard of undeclared allergens.
2. 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." However, your firm’s revised HACCP plan provided in your June 20th response does not list a critical limit that is adequate at the “Receiving” critical control point, associated with the “organoleptic” evaluation. Specifically, while you set a critical limit of (b)(4), this score does not appear to be associated with your failure rate and does not ensure that FDA’s recommended critical limit of less than 2.5% is met.
3. 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 actions included in your revised HACCP plan provided in your June 20th response are not adequate to control histamine formation. Specifically,
a. Your actions listed at the “Receiving” critical control point do not address correcting the cause of the deviations.
b. Your actions listed at the “Chilling Room” critical control point do not ensure that an appropriate number of fish will be tested for histamine, to represent the entire lot. FDA recommends a minimum of 60 fish or all of the fish for lots that container fewer than 60 fish.
4. We acknowledge descriptions of corrections of several sanitation deviations, however, the following observations have not been addressed or corrected, in accordance with 21 CFR 123.11(b). Specifically,
a. safety of Water, in that the threaded water faucet lying on the dock behind the factory building and other faucets throughout the facility did not have backflow prevention devices.
b. condition and cleanliness of food contact surfaces, in that cleavers and knives for cutting tuna had wooden handles.
c. exclusion of pests, in that a drain fly was observed in the de-heading room
Please refer to Chapter 7 of the Fish and Fisheries Products Hazards & Controls Guidance: Fourth Edition for additional information related to the hazard of Scombrotoxin (Histamine) Formation. Please refer to Chapter 13 for information related to Clostridium botulinum and Chapter 19 for information related to undeclared allergens.
You should respond in writing within thirty (30) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. Your response should include documentation, such as: a copy of any revised HACCP plans; at least five (5) product days worth of monitoring records to demonstrate that you have implemented the revised plan; any verification records; and any other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections within fifteen days, you should explain the reason for your delay and state when you will correct any remaining violations.
If you do not respond or if we find your response inadequate, we may take further action. For instance, we may take further action to refuse admission of your imported fish or fishery products under Section 801(a) of the Act (21 U.S.C. §381(a)), including placing them on detention without physical examination (DWPE). FDA’s DWPE is an administrative procedure whereby products offered for import into the United States may be detained without physical examination upon entry. DWPE information may be conveyed in FDA’s Import Alerts. For your information, an example of an Import Alert that conveys information specific to foreign firms that are not in compliance with the seafood HACCP regulation is Import Alert #16-120. This alert can be found on FDA’s web site at: http://www.fda.gov/ora/fiars/ora_import_ia16120.html.
This letter may not list all your deviations from the requirements of the Act or applicable regulations. You are responsible for ensuring that your processing plant operates in compliance with the Act, the Seafood HACCP regulation, and the Current Good Manufacturing Practice regulations (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Please direct your response the Food and Drug Administration, Attention: Mildred Benjamin, Consumer Safety Officer, Office of Compliance, Division of Enforcement, Manufacturing and Storage Adulteration Branch (HFS-607), 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Ms. Benjamin by phone at (240) 402-1424 or via email at Mildred.Benjamin@fda.hhs.gov
Office of Compliance
Center for Food Safety
and Applied Nutrition
Ms. Novanina Pinangkaan
P.T. Bitung Mina Utama
Jl Aertembaga 2 Lingkungan 2
Bitung, North Sulawesi 95526 Indonesia