- Peter Bacle dba Stock Island Lobster Company
- Issuing Office:
- Florida District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Florida District|
555 Winderley Place, Suite 200
Maitland, Florida 32751
Telephone: 407-475-4700 Fax: 407-475-4770
VIA UPS NEXT DAY AIR
w/ DELIVERY CONFIRMATION
August 1, 2014
Peter A. Bacle
Stock Island Lobster Company
6639 Maloney Avenue
Key West, Florida 33040
Dear Mr. Bacle:
We inspected your seafood processing facility, located at 6639 Maloney Avenue, Key West, Florida 33040 on May 1- 2, 2014. 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 regulations 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 fresh King Mackerel, raw and gutted with head on, 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 & Controls Guidance through links in FDA's home page at www.fda.gov
Your significant violations were as follows:
1. 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 (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 King Mackerel, raw and gutted with head on, does not list the critical control point of “Packaging” with the “Allergen” food hazard.
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 point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard. However, your firm’s HACCP plan for King Mackerel, raw and gutted with head on lists a critical limit at the receiving critical control point that is not adequate to control for Scombrotoxin (Histamine) Formation.
3. 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 procedures for your King Mackerel, raw and gutted with head on, at the receiving critical control point to control for the natural toxins from ciguatoxin and at the receiving and storage critical control points to control for histamine formation, due to time/temperature abuse. Specifically,
a) You do not determine the location of harvest for each lot of King Mackerel at the time of receipt, but rather you obtain the required information after the lot has been sold and more specifically at the time that the harvest vessel receives payment.
b) You do not determine the adequacy of ice surrounding your King Mackerel product twice daily, as required in your HACCP plan at the storage CCP, but rather in practice you monitor for the presence of ice once daily as is documented on your sanitation log indicating that one check per day occurred. On May 2, 2014, the ice surrounding your King Mackerel was checked as “adequate” even though the fish was observed to be protruding extensively from its packaging container and was not covered completely in ice. The walk-in cooler ambient temperature was observed to be 47.7°F.
This is a repeat observation from Form FDA 483 (FDA 483) Observation 3, dated January 30, 2008; FDA 483 Observation 2, dated April 5, 2007; and FDA 483 Observation 1, dated February 16, 2006.
4. You must verify that your HACCP plan is adequate to control food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.8(a). However, your firm did not verify the adequacy of the critical limit of “not harvesting from designated areas” for King Mackerel at the receiving critical control point to control for natural toxins from ciguatoxin and additionally you did not verify the adequacy of the critical limit(s) of “sensory evaluation of each shipment”, “fish to be fully covered and surrounded by ice”, “harvest vessel verification record-see dock ticket”, “maintain temperature control cooler and keep histamine type fish iced while in cooler”, “product completely covered in ice throughout storage” for King Mackerel at the receiving and storage critical control point to control scombrotoxin (histamine) due to time/temperature abuse as evidenced by:
a) You do not review and verify harvest vessel records or advisories to determine the location of harvest for each lot of King Mackerel at the time of receipt to determine if the lot of fish should have been rejected, but rather in practice you obtain and record harvest location information on the trip ticket after the sale of the lot at the time the harvest vessel collects payment. There is no review of harvest location information.
b) You do not make and keep a record for the review and verification of the rejection of King Mackerel for sensory failure at time of receipt. In practice, you do not record the sensory examination results for decomposition of individual fish, but rather you record the entire lot of fish as “accepted”, unless greater than 20 fish fail the sensory examination due to decomposition. You do not make and keep a record of the rejection of individual fish at time of receipt.
c) You do not make and keep an accurate record for the review and verification of the internal temperature of King Mackerel, gutted with head on, for temperature abuse at time of receipt, but rather in practice you take the internal temperature of one fish per lot and if a reading above 38°F is obtained the fish is iced for (b)(4) minutes and if the temperature is lowered then the lot of fish is accepted. Additionally, you do not review and verify harvest vessel records at time of receipt to ensure that incoming fish were properly handled onboard the harvest vessel.
d) You do not make and keep accurate records for the review and verification of your monitoring activities associated with your King Mackerel, gutted with head on. For example, on May 2, 2014 your employee was observed in the performance of conducting your sanitation check. The employee was observed documenting that your King Mackerel fish was adequately covered in ice even though it was not surrounded by ice. The ambient walk-in cooler temperature was observed to be 47.7°F. The receiving ticket dated May 2, 2014 for (b)(4) pounds of King Mackerel reflected this fish was received without a sensory or temperature check.
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 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), and is registered in accordance with the Food Facility Registration regulation (21 CFR Part 1, Subpart H). 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 Food and Drug Administration, Attention: Randall L. Morris, Compliance Officer at 555 Winderley Place, Suite 200, Maitland, FL 32751. If you have questions regarding any issues in this letter, please contact Randall L. Morris, Compliance Officer at (407) 475-4741.
Elizabeth W. Ormond
Acting Director, Florida District