WARNING LETTER
Port Clyde Fresh Catch, Inc.
MARCS-CMS 581353 —
July 15, 2019
Delivery Method:
VIA UNITED PARCEL SERVICE
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Glen A. Libby
Recipient Title
President
Port Clyde Fresh Catch, Inc.
18 Lobster Pound Rd.
Port Clyde
,
ME
04855
United States
Issuing Office:
Division of Human and Animal Food Operations East I
158-15 Liberty Avenue
Jamaica
,
NY
11433
United States
WARNING LETTER
CMS #581353
VIA UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
Mr. Glen A. Libby,
President
Port Clyde Fresh Catch, Inc.
18 Lobster Pound Rd.
Port Clyde, ME 04855
Dear Mr. Libby:
The United States Food and Drug Administration (FDA) inspected your seafood processing facility, Port Clyde Fresh Catch, Inc. located at 18 Lobster Pound Rd., Port Clyde, ME 04855 on April 16
th
- 18
th
, & 25
th
, 2019.
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 refrigerated, ready-to-eat, cooked crabmeat and frozen, ready-to-eat crabmeat in vacuum packages
are
adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they
may be rendered injurious to health.  You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance (the Hazards Guide) through links in FDA's home page at
www.fda.gov
.
We acknowledge receipt of your written response, received in our office on May 17, 2019, to the deviations observed during the inspection and listed on the Form FDA 483, Inspectional Observations (FDA 483) issued to you on April 25, 2019.  We have evaluated your response and discuss your corrective actions relative to each item below.
Your significant violations are as follows:
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 plan for cooked, ready-to-eat crabmeat titled “
(b)(4)
” collected during the inspection (without a date) lists critical limits at the “
(b)(4)
”, “
(b)(4)
”, and “
(b)(4)
” critical control points that are not adequate. Specifically,
During our inspection, the critical control point of “
(b)(4)
” listed a critical limit of
“
(b)(4)
”
that is not adequate to control the food safety hazard of pathogen growth and toxin formation.
Your firm indicated that your cooking process is not established by a scientific study to demonstrate that this critical limit and your current process is sufficient to control the
food safety hazard of pathogenic bacteria (
Listeria monocytogenes
) survival through cooking
. It was observed that you start your
(b)(4)
.
Furthermore, since your firm was unaware of the processing temperatures and did not have a thermometer at your facility, our investigator observed the internal product temperatures of crab at the end of the cooking step (after
(b)(4)
cooking time) on April 17, 2019 and April 18, 2019 with an FDA calibrated thermometer that revealed the following results:
Date        Batch #             Internal Temp
4/17/19       1                   140° F
4/17/19       4                   143° F
4/18/19       1                   155.7° F
4/18/19       2                   150° F
4/18/19       3                   122.3° F
4/18/19       4                   136° F
4/18/19       5                   128.8° F
When this information was brought to management’s attention you did not take corrective action and your firm continued to process, package, and ship the batches of ready-to-eat crabmeat from the batches listed above.
Your written FDA-483 response indicates that you have updated your critical limit at the “
(b)(4)
” critical control point in your HACCP plan to “
(b)(4)
” that continues to be inadequate to control the food safety hazard of pathogen growth and toxin formation.  In addition, your response failed to provide a more detailed explanation of how this cook process was developed in order to ensure a minimum 6 log reduction of Listeria monocytogenes in all cooked units so that all crabs achieve an adequate cook. FDA recommends you set critical limits established by a scientific study for critical factors of the cooking process (such as cooking temperature, size of the product, length of cook, etc.) or end point internal product temperature, in order to ensure a minimum 6-log reduction in all cooked units.
During our inspection, the critical control point of “
(b)(4)
” listed a critical limit of
“
(b)(4)
” that is not adequate to control pathogen growth and toxin formation. The critical limit does not list a time limit or time and temperature parameters to be met in order to control the hazard of pathogen growth and toxin formation. In practice, after the cooking step, your firm
(b)(4)
before processing begins. During the inspection the FDA investigator took the internal temperature of cooked crabs at the end of cooling/start of processing and found a range of temperatures between 108° F – 120° F. In addition, your firm does not list any monitoring procedures at the “
(b)(4)
” critical control point.
Your written FDA-483 response indicates that you have updated your critical limit at the “
(b)(4)
’” critical control point to state “
(b)(4)
.”  However, the critical limit continues to be inadequate because it continues to lack a time parameter.  FDA recommends the product be cooled from 135° F to 70° F within 2 hours and further cooled to 40° F within an additional 4 hours before significant handling/processing begins.
During our inspection, the critical control point of “
(b)(4)
” listed a
critical limit of “
(b)(4)
” that is not adequate to control pathogen growth and toxin formation.  FDA recommends that cumulative unrefrigerated processing time (from handling the product until the product is back to 40°F or below) be limited to 5 hours when the ambient processing temperatures do not exceed 70°F.  Also, your listed monitoring procedure that includes “
(b)(4)
” is not adequate to control pathogen growth and toxin formation. In practice your firm conducts significant handling/processing of the product at unrefrigerated temperatures (ambient room temperature
(b)(4)
°F -
(b)(4)
°F). On April 16, 2019 and April 17, 2019, the investigator observed that the ice at the bottom of the containers was melted and there was not enough ice to sufficiently surround the crab parts. Also, by the time the containers were emptied out onto the processing table there was no ice left.  The handling/processing of the crabs was conducted from
(b)(4)
.   Since significant handling/processing of the ready-to-eat crabs and crabmeat occurs after the heating process and is at ambient temperatures above 40°F, cumulative time and temperature exposure controls should start once the product is below 135°F and handled.  Cumulative time and temperature exposure controls should end when the product is back to 40°F or below.
Your written FDA-483 response indicates
that you have updated your critical limit at the “
(b)(4)
” critical control point to “
(b)(4)
.”  However, the critical limit continues to be inadequate.
As stated above, FDA recommends that cumulative unrefrigerated processing time (from handling the product until the product is back to 40°F or below) be limited to 5 hours when the ambient processing temperatures do not exceed 70°F.
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 plan for
cooked, ready-to-eat crabmeat titled “
(b)(4)
” collected during the inspection (without a date) does not identify the following hazards:
Your HACCP plan fails to identify the hazard of
Clostridium botulinum
for frozen, ready-to-eat, cooked crabmeat in vacuum packages. FDA recommends that you ensure that each individual vacuum package includes instructions to be held frozen and to be thawed under refrigeration immediately before use (e.g., “Keep Frozen, Thaw Under Refrigeration Immediately Before Use”).
Your HACCP Plan does not list the food safety hazard of allergens. The allergen hazard is reasonably likely to occur because crabs are a crustacean shellfish, one of the eight major food allergens.
Your written FDA-483 response states that it includes a copy of your entire revised HACCP plan.  However, we have reviewed the HACCP plan you provided, and it continues to fail to identify and list the food safety hazards of
Clostridium botulinum
and allergens.
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 117, sub part B, to comply with 21 CFR 123.11(b).  However, your firm did not monitor the safety of water that comes into contact with food or food contact surfaces, including water used to manufacture ice, condition and 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 and proper labeling, storage and use of toxic chemicals with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 117 as evidenced by the following observations made by our FDA Investigator during our inspection:
On 04/17-18/2019 the FDA Investigator observed cooked crab parts that fell on the ground of the cooking/cooling vessel room were picked up off the floor and brought to the crab picking/processing room where they were co-mingled with other cooked crab parts to be picked and packaged as a ready-to-eat product.
On 04/17-18/2019 the FDA Investigator observed
an employee touching the ground to remove debris from a large open hole in the concrete floor that houses plumbing and touching objects in a rubbish pile outside behind crates of live crab. The employee returned to cooking and cooling cooked crab without washing and sanitizing hands or changing gloves. In addition, employees were observed to leave their work station to move crates of discarded crab shells outside and other job tasks. Employees put on a new set of gloves without washing and sanitizing their hands, used their uncleaned hand to adjust the first glove, and returned to picking cooked, ready-to-eat crabmeat.
On 04/17/19 the FDA Investigator observed
an employee scrubbing and rinsing the cooking and cooling vessels with cold water only. The brush that was used was later observed to be stored with the bristles directly touching the floor.
On 04/17/19 the FDA Investigator observed
a hose used to continually fill the cooling vessel and another hose used to rinse off food contact surfaces in the processing room were stored on the processing room floor.
On 04/17/19 the FDA Investigator observed the use of
sanitizer solution "
(b)(4)
" mixed with water at a
(b)(4)
ratio to wipe down tables where ready-to-eat hand-picked crab meat is processed.  This sanitizer is not approved for sanitizing food contact surfaces.
On 04/17/19 the FDA Investigator observed
an employee drain the water out of the cooking and cooling vessel. The water flowed directly under the door and into the processing room while other employees were processing ready-to-eat crabmeat.
Your written FDA-483 response does appear to provide correction to some of the above observations such as handwashing before putting on gloves and after exiting the processing room and disinfecting all surfaces per manufacturer’s instructions after surfaces are washed and future use of the appropriate sanitizing agent.   Your response does not specifically described how you have addressed the storage of brushes and hoses off the floor. Your response does not include your plan to prevent these violations from recurring.  Additionally, we are unable to fully assess your promised corrective actions as we do not have enough information and consequently cannot verify the adequacy of these corrections you have or will implement.  We will verify the adequacy of your corrective actions during a future inspection.
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 listed at the
“
(b)(4)
”, “
(b)(4)
”, “
(b)(4)
”, and “
(b)(4)
” critical control points
in
your firm’s HACCP plan for cooked, ready-to-eat crabmeat titled “
(b)(4)
” collected during the inspection (without a date) are not adequate because they do not ensure adulterated products do not enter commerce and the cause of the deviation is corrected.
Your written FDA-483 response provides a revised HACCP plan.   However, the revisions to the corrective actions listed in your revised HACCP plan for the critical control points of “
(b)(4)
”, “
(b)(4)
”, “
(b)(4)
”, and “
(b)(4)
” are not adequate because they do not ensure adulterated products do not enter commerce and the cause of the deviation is corrected.
Registration Requirement
In addition, the Food and Drug Administration has determined that your facility is subject to the registration requirement in Section 415 of the Act (21 U.S.C. § 350d) and our implementing regulation at 21 CFR Part 1, Subpart H. The failure to register a facility as required is a prohibited act under Section 301(dd) of the Act (21 U.S.C. § 331(dd).
(b)(3)(A)
.
The owner, operator, or agent in charge of your facility, or an individual authorized by your facility's owner, operator, or agent in charge, should register the facility with FDA immediately. Registration may be accomplished on-line at
http://www.access.fda.gov
. We strongly encourage the use of electronic registration because it will result in an automatic confirmation of registration and automatic issuance of a registration number.
Alternatively, the owner, operator, or agent in charge of this facility, or an individual authorized by the facility's owner, operator, or agent in charge, may register the facility by mail or fax (e.g., if you do not have reasonable access to the Internet) using FDA's food facility registration form, Form 3537. This form may be obtained by calling the FDA Industry Systems Help Desk at 1-800-216-7331 or 301-575-0156, or by writing to the agency at the following address:
U.S. Food and Drug Administration, HFS-681
5600 Fishers Lane
Rockville, MD 20857
When completed, the form may be faxed to (301) 210-0247 or mailed to the address above. FDA will process registrations submitted by mail or fax and provide a facility's registration number using the same method used to submit the registration to FDA.
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 in violation of Section 402(a)(4) of the Act (21 U.S.C. § 342(a)(4) and the seafood HAACP regulation.  We may also take further action to enjoin your firm from operating in violation of Section 415 of the Act (21 U.S.C. § 350d) and 21 CFR Part 1, Subpart H.
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 117) 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 U.S. Food and Drug Administration, Attention: Michael R. Dominick, Compliance Officer, 222 Bloomingdale Road, Suite 406, White Plains, NY 10601.  If you have questions regarding any issues in this letter, please contact Michael R. Dominick
at 914-682-2826 ext. 20 or email at Michael.Dominick@fda.hhs.gov.
Sincerely,
/S/
Ronald Pace
Program Division Director
Office of Human and Animal Food Operations -
East Division 1
Content current as of:
07/30/2019
Regulated Product(s)
Food & Beverages