Inspections, Compliance, Enforcement, and Criminal Investigations
Martex Farms S.E. 15-Feb-07
Department of Health and Human Services
Public Health Service
San Juan District
TEL (787) 474-9500
February 15, 2007
RETURN RECEIPT REQUESTED
Mr. Venancio Marti Santacruz
Martex Farms S.E.
P.O. Box 3402
Carolina, P.R. 00984
Dear Mr. Marti Santacruz:
We inspected your firm, located at road number 545, Sector Obdulia, Paso Seco, Santa Isabel, Puerto Rico 00757, on September 22-28, 2006 and found that you have a serious violation of the juice Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 120, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 120 & 110). In accordance with 21 CFR 120.9, failure of a processor of juice products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 120, renders the juice 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 'limon criollo', 'mamey sapote', 'mango', and 'papaya' juice products 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 this Act and the juice HACCP regulations through links in FDA's home page at www.fda.gov.
The violation was as follows:
You must have a HACCP plan that lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 120.8(b)(1). However, your firm's HACCP plans for 'limon criollo', 'mamey sapote', 'mango', and 'papaya' juice products do not list the food safety hazard of pathogens.
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 juice HACCP regulation (21 CFR Part 120) 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.
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.
Please send your reply to the Food and Drug Administration, Attention: Mr. Carlos A. Medina, Compliance Officer at 466 Fernandez Juncos Avenue, San Juan, Puerto Rico 00901-3223. If you have questions regarding any issue in this letter, please contact Mr. Medina at 787-474-9538 or email@example.com.
Enclosure: FDA 483