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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Browne Trading Co. 10/29/13

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 New England District Office
One Montvale Avenue, 4th floor
Stoneham, MA 02180
Phone 781.587.7500
Fax 781.587.7556

 

AMENDED WARNING LETTER
 
CMS # 408828
 
                                                                                                           
UNITED PARCEL SERVICE
OVERNIGHT DELIVERY
 
 
October 29, 2013
 
Mr. Rod Mitchell
President
Browne Trading Company
260 Commercial Street
Portland, ME 04101
                                                                       
Dear Mr. Mitchell:
 
The United States Food and Drug Administration (FDA) inspected your seafood processing facility, located at 260 Commercial Street, Portland, ME on May 23 through July 11, 2013.   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 (21 CFR 123). 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 seafood products, including your ready-to-eat (RTE) refrigerated vacuum packed cold-smoked salmon, refrigerated vacuum packed cold smoked haddock, refrigerated vacuum packed cold smoked shrimp meat, refrigerated vacuum packed cold smoked mussel meat, refrigerated vacuum packed hot smoked salmon, refrigerated vacuum packed hot smoked scallop, refrigerated vacuum packed hot smoked trout, and refrigerated vacuum packed hot smoked sturgeon  are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they 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.
 
We acknowledge the receipt of your letter, received August 13, 2013, in response to the form FDA 483, Inspectional Observations, issued to you on July 18, 2013. However, your response is not adequate in that it did not include any revised HACCP plans for review. To determine the adequacy of your response, we will need to evaluate your complete HACCP plans in their entirety.  The deviations listed in this letter are based on the inspection and our review of your firm’s HACCP plans for refrigerated vacuum packed cold smoked salmon; refrigerated vacuum packed cold smoked haddock; refrigerated vacuum packed cold smoked shrimp meat; refrigerated vacuum packed cold smoked mussel meat; refrigerated vacuum packed hot smoked salmon; refrigerated vacuum packed hot smoked scallop; refrigerated vacuum packed hot smoked trout; and refrigerated vacuum packed hot smoked sturgeon that were collected during the inspection.   Your significant violations are as follows:
  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 HACCP plans for refrigerated vacuum packed cold smoked salmon; refrigerated vacuum packed cold smoked haddock; refrigerated vacuum packed cold smoked shrimp meat; refrigerated vacuum packed hot smoked salmon; refrigerated vacuum packed hot smoked trout; and refrigerated vacuum packed hot smoked sturgeon do not identify the food safety hazard of undeclared allergens.
 
FDA recommends that firms include a critical control point to monitor each batch of labels to ensure that labels declare the allergenic substances. Finfish species must be identified on the label by the correct common or usual name. Additionally, other ingredients such as soy sauce which may contain two food major allergens, soy and wheat, in your finished products need to be addressed in your HACCP plans, when necessary. We suggest that processors conduct a visual examination of their labels prior to use by comparing the label with product to be labeled to ensure that all allergenic ingredients are accurately declared.
 
 
  1. 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 HACCP plans for ready-to-eat smoked seafood products do not list critical limits that are adequate to control pathogen growth including Clostridium botulinum growth and toxin formation. Specifically;
 
·         The HACCP plans for your cold smoked products list critical limits at the “Receiving” critical control point that are not adequate to control pathogen growth. While the critical limits include monitoring for sufficient cooling media upon receipt, this alone is not adequate. In addition to cooling media, we recommend firms also include a critical limit associated with the internal temperature of the product at the time of delivery to ensure that product temperatures do not exceed 40⁰F.
 
·         The HACCP plans for your hot smoked and cold smoked products list critical limits at the “Chilled Storage conditions including raw product before processing, & Brine and Filler process performed under chilled storage conditions & Thawing of previously frozen product & any holding time between processing steps under chilled storage conditions & cooling process performed under chilled storage conditions & storage after processing & packaging” critical control point in each of the plans that are not adequate to control pathogen growth, including Clostridium botulinum growth and toxin formation. The critical limits in these plans are listed as:
 
“Ambient cooler temperature will not exceed (b)(4) With the following maximum exposure times in event of deviation resulting in PRODUCT TEMP exceeding (b)(4) for more than (b)(4) hours, OR temperatures above and below (b)(4)F for more than (b)(4) hours OR greater than (b)(4)F but less than (b)(4)F for more than (b)(4)F for more than (b)(4) hours (Page 152, 279, &282) OR greater than (b)(4)F but less than (b)(4)F for more than (b)(4) hours (Page 84) re scombrotoxin is only stated max exposure between (b)(4) found.” 
 
These critical limits are not appropriate because the combined exposure times and temperatures that are included as critical limits are associated with deviations and are not appropriate as the actual critical limits.
 
·         The HACCP plans for your refrigerated vacuum packed cold smoked salmon; refrigerated vacuum packed cold smoked haddock; refrigerated vacuum packed hot smoked sturgeon; refrigerated vacuum packed hot smoked salmon; refrigerated vacuum packed hot smoked trout; refrigerated vacuum packed cold smoked shrimp; refrigerated vacuum packed cold smoked mussel; and refrigerated vacuum packed hot smoked scallop list critical limits at the “Brining” critical control point in each of the plans that are not adequate to control pathogen growth including Clostridium botulinum growth and toxin formation. 
 
Your plans list either “(b)(4) salt to sugar ratio in all dry brine mixtures; brine to fish ratio of (b)(4) brine to (b)(4) of seafood.” or “Wet brines salinity of min (b)(4). Brine to fish ratio a minimum of (b)(4) of brine to (b)(4) of seafood (b)(4); Min time (b)(4) hours.” These listed critical limits for the brining step do not ensure that an adequate water phase salt content will be consistently achieved in each batch for each product.    
 
Below we have provided a table which is a compilation of the verification testing results we assessed for your products. The bolded values show water activities and water phase salt results that are inadequate as a secondary barrier for your refrigerated vacuum-packed finished products.
 
Results from Browne Trading Company’s Quarterly Testing of Water Activity (aw) and Water Phase Salt (WPS).
Product
Quarter
Production
date
Sample date
Lot
aw
 
WPS (%)
HS trout
3rd-2012
 
8/14/12
(b)(4)
(b)(4)
(b)(4)
HS trout
4th 2012
 
No sample
 
 
 
HS trout
1st -2013
 
3/28/13
(b)(4)
(b)(4)
(b)(4)
CS haddock
3rd-2012
 
8/6/12
(b)(4)
(b)(4)
 
CS haddock
4th-2012
11/5/12
11/9/13
(b)(4)
(b)(4)
 
CS haddock
1st-2013
 
3/28/13
(b)(4)
(b)(4)
(b)(4)
CS Shrimp
3rd-2012
 
8/6/12
(b)(4)
(b)(4)
(b)(4)
CS Shrimp
4th-2012
10/15/12
11/9/12
(b)(4)
(b)(4)
 
CS Shrimp
1st-2013
1/18/13
3/28/13
(b)(4)
(b)(4)
(b)(4)
CS Mussel
3rd-2012
 
8/7/12
(b)(4)
(b)(4)
 
CS Mussel
4th-2012
8/12/12
11/9/12
(b)(4)
(b)(4)
 
CS Mussel
1st-2013
11/21/13
3/28/13
(b)(4)
(b)(4)
(b)(4)
HS Scallop
3rd-2012
 
8/6/12
(b)(4)
(b)(4)
 
HS Scallop
4th-2012
 
11/9/12
(b)(4)
(b)(4)
 
HS Scallop
1st-2013
 
3/28/13
(b)(4)
(b)(4)
(b)(4)
 
The table demonstrates verification results where your finished products did not consistently achieve a water activity value of (b)(4) or less; OR a water phase salt level above (b)(4), which are the values listed in your plans as verification for controlling Clostridium botulinum growth and toxin formation.   These results also appear to indicate that your firm has not verified the adequacy of your HACCP plans for controlling the identified food safety hazards, in compliance with 21 CFR 123.8(a). 
 
As an alternative to controlling water activity or water phase salt in your vacuum packaged refrigerated products, your firm may want to consider either using time temperature indicators (TTIs) on each individual package or freezing the finished product. 
 
  1. You must implement the record keeping system that you listed in your HACCP plan, to comply with 21 CFR 123.6(b). However, your firm did not record monitoring observations of “Fish to brine ratio for each lot” at your “Brining” critical control point in your “Cold smoked vacuum packed salmon.” Specifically, our investigator found that your firm is not documenting this information for your dry brine process.
 
  1. 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 and frequency for “Adequacy of cooling media on at least 3 sides and Taking product temperature” in “Every box received” at your “Receiving” critical control point to control pathogens listed in your “Cold smoked vacuum packed salmon” HACCP plan. Specifically, our investigator observed that on November 29, 2012, the presence of frozen gel coolant and product internal temperatures were only recorded in 12 out of (b)(4) cases of salmon and on May 23, 2013 the presence of frozen gel coolant and product internal temperatures were only recorded in 6 out of (b)(4) cases of salmon.
 
  1. 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 are not appropriate, as follows:
 
·         All of your smoked fish HACP plans list corrective action plans at the critical control points of “Chilled Storage conditions including raw product before processing, & Brine and Filler process performed under chilled storage conditions & Thawing of previously frozen product & any holding time between processing steps under chilled storage conditions & cooling process performed under chilled storage conditions &storage after processing & packaging” that are not appropriate. All the plans include holding the products and conducting microbiological end product testing. However, when a deviation from the critical limit occurs during storage it is not appropriate to use microbiological testing to determine the safety of the product. Testing will not ensure that all affected product is safe. We encourage, instead, evaluating time and temperature exposures to determine the level of safety for the affected lots of product.
 
·         Your cold smoked HACCP plans list corrective action plans at the critical control points of “Receiving (Initial receipt into plant)” as “Reject all product without adequate cooling media unless maximum exposure to temperatures over (b)(4)F can be confirmed to be less than (b)(4) hours” that are not adequate because the actions do not address correcting the cause of the critical limit deviation. We recommend when a deviation from the critical limit occurs during receiving that, in addition to rejecting the lot and determining exposure time, firms take measures to ensure that the supplier has corrected the source of the deviation.
 
·         Your cold smoked HACCP plans list corrective action plans at the critical control points of “Smoking” as “Hot smoke product if exceed (b)(4) degrees or use non vacuum packaging (e.g. butcher paper) (pg.182)” which are not adequate because the actions do not address correcting cause of the critical limit deviation. We recommend when a deviation occurs during smoking that, in addition to taking a corrective action associated with the product, that firms also make repairs or adjustment to the smoker. This applies also to your hot smoked product HACCP plans at this same “Smoking” critical control point. The corrective actions listed as “Return product to smoker until internal product temperature of minimum (b)(4) degrees form minimum (b)(4) has been achieved OR Hold until product safety has been tested (WPS or Water Activity) OR Do not package in oxygen reduced packaging” are not adequate because they do not address correcting the cause of the critical limit deviation, such as making repairs or adjustments to the smoker.
 
  1. You must take a corrective action whenever a verification procedure reveals the need to take a corrective action to comply with 21 CFR 123.8(b). Corrective actions are required to be in accordance with 21 CFR 123.7. Sections 123.7(b) and (c) require that a corrective action ensures that no product enters commerce that is either injurious to health or is otherwise adulterated as a result of the deviation and that the cause of the deviation is corrected.   Your firm did not take adequate corrective actions to control pathogen growth including Clostridium botulinum growth and toxin formation in finished product when your verification testing determined that your critical limits has not been met. Corrective actions should address the affected products and correct the cause of the deviation to prevent the deviation from occurring again. You were unable to provide information to indicate that appropriate corrective actions were taken.
 
  1. 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 and to comply with 21 CFR 123.11(b). However, your firm did not monitor the condition and cleanliness of food contact surfaces; the prevention of cross-contamination from insanitary objects; and the protection of food, food packaging material, and food contact surfaces from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate, and other chemical, physical, and biological contaminants with sufficient frequency as evidenced by:
    1. The thermometer probe that you use to measure the internal temperature of fish and fishery products and its storage holster was observed with accumulation of dark residue.
    2. The top of the stock sanitizer container with ½ inch opening that feeds into the sanitizer dispensing system used to sanitize the food contact surfaces was observed to be covered with unknown brown residue. 
    3. Sections of floor at the entrances of two bays of the smoked seafood cooler were rusted and pitted.
  1. Failure to enter processing information or other information on your records at the time it was observed, to comply with 21 CFR 123.9(a).   On May 23, 2013, we observed an employee entering sanitation inspection results for a different employee an hour after the sanitation inspection was performed.
 
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: Karen N. Archdeacon, One Montvale Avenue, Stoneham, MA 02180. If you have questions regarding any issues in this letter, please contact Ms. Archdeacon at 781-587-7491.
 
 
Sincerely,
/S/
Amber G. Wardwell.
Acting District Director
New England District Office