| Public Health Service Food and Drug Administration |
Baltimore District Office |
Department of Health and Human ServicesFEI: 3005719169
WARNING LETTER
CMS# 180377
May 16, 2011
Certified Mail
Return Receipt Requested
Ms. Joan A. Ribadulla, Co-Owner
Manolo and Son, LLC
1230-8 N. Henry Street
Alexandria, VA 22314
Dear Ms. Ribadulla:
We inspected your seafood processing facility, located at 1230-8 N. Henry Street, Alexandria, VA on March 9-15, 2011. 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 offish 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 canned pasteurized crabmeat 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 fourth edition to the Fish and Fisheries Products Hazards & Controls Guidance (The Guide) through links in FDA's home page at www.fda.gov.
Your significant violations were as follows:
• You must have a HACCP plan that at a minimum lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6 (c)(4). However, your firm's HACCP plan for canned pasteurized crabmeat lists a monitoring procedure" (b)(4) , that is not adequate to control the hazard of pathogen growth and toxin formation at the (b)(4), critical control point. In addition to taking temperatures at receipt, FDA recommends that you require either the internal temperature of the product throughout transportation; or the ambient temperature within the truck or other carrier throughout transportation as a condition of receipt of refrigerated seafood. Alternatively, you may make (and record) visual observations of the adequacy of ice in a representative number of containers (e.g., cartons and totes) from throughout the shipment at delivery.
Further, your monitoring frequency, "(b)(4) at frequency of (b)(4) day at the (b)(4) critical control point is not adequate to control the hazard of pathogen growth and toxin formation. FDA recommends that you either continuously monitor or record the ambient air temperature, or for storage under ice: the adequacy of ice surrounding the product. If you monitor the adequacy of ice, you should monitor and record the observations at a frequency that will assure compliance with the critical limit. We note that at the time of our inspection, a representative of your firm was unable to make available for FDA review the temperature monitoring records for the cooler.
• 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 plan, "(b)(4)" at the "(b)(4)" critical control point and your corrective action plan, "(b)(4)" critical control point are not adequate because they do not ensure that the cause of the deviation is corrected or that no product enters commerce that is either injurious to health or is otherwise adulterated as a result of the deviation.
We received your letter on March 22,2011 responding to the FDA-483. Your response does not adequately address the significant observations noted in the FDA-483. Specifically, your HACCP plan for canned pasteurized crabmeat failed to include receiving and cold storage critical control points (CCPs) and failed to adequately address the monitoring procedures, corrective actions, verification procedures, and record-keeping procedures.
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.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violation(s), or similar violation(s), from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur overtime, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
You should know that this letter is not intended to be an all-inclusive list of the violation(s) at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violation(s) noted in this letter and in the Inspectional Observations, Form FDA-483 (FDA-483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of the violation(s), and take prompt actions to correct the violation(s) and to bring your products into compliance.
Your response should be sent to: U.S. Food and Drug Administration, Attention: Cherlita Honeycutt, Compliance Officer, 6000 Metro Drive, Suite 101, Baltimore, MD 21215. If you have questions regarding any issues in this letter, please contact Ms. Honeycutt at (410) 779-5412.
Sincerely yours,
/S/
Evelyn Bonnin
District Director
Baltimore District Office
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