Inspections, Compliance, Enforcement, and Criminal Investigations
Hispamer Distributors, Inc. 10-Aug-05
Department of Health and Human Services
Public Health Service
555 Winderley Pl., Ste. 200
RETURN RECEIPT REQUESTED
August 10, 2005
Carlos Marin, President
Hispamer Distributors, Inc.
350 NE 75th Street
Miami, Florida 33138-4927
Dear Mr. Marin:
On June 7, 13, 16 and 17, 2005, the United States Food and Drug Administration (FDA) conducted an inspection of your facility located at the above listed address. We found that you have serious deviations from the seafood Hazard Analysis and Critical Control Point (HACCP) regulations, Title 21 Code of Federal Regulations, (21 CFR Part 123). In accordance with 21 CFR 123 .6(g), failure of a processor to have and implement a HACCP plan that complies with this section or to otherwise operate in accordance with the requirements of 21 CFR Part 123, renders your seafood 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 are adulterated, in that they have been prepared, packed, or held under insanitary conditions where by they may have been rendered injurious to health. You may find the Act and the seafood HACCP regulations through links in the FDA's home page at www.fda.gov.
During our inspection, the FDA Investigator provided your General Manager, Manuel B. Rodriguez, with a copy of the Form FDA 483 (copy enclosed). The deviations observed included the following:
1. You must conduct, or have conducted for you, a hazard analysis for each kind of fish or fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur, and you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (b). However, your firm does not have a HACCP plan for vacuum packed anchovies and sardines to control the hazards of C. Botulinum pathogen growth and temperature abuse.
2. You must maintain sanitation control records that, at a minimum, document monitoring and corrections, to comply with 21 CFR 123.11(c). However, your firm did not maintain any sanitation monitoring records for: the maintenance of hand washing, hand sanitizing, toilet facilities; protection of food, food packaging material, and food contact surfaces from adulteration ; proper labeling, storage and use of toxic compounds; control of employee health conditions that could result in the microbiological contamination of food, food packaging materials, and food contact surfaces; and exclusion of pests from the facility. [redacted] and [redacted] informed the FDA investigator stating that they maintained no daily sanitation checklist.
3. You failed to calibrate your process-monitoring instruments to ensure that they read accurately, and you failed to maintain your calibration records in accordance with 21 CFR 123.8(a)(2)(ii) and 21 CFR 123.8(d). For example, on 6/7/05, the FDA Investigator observed that the thermometer located on the outside of the reach-in cooler was broken and the needle was reading 30 degrees when, in fact, the temperature inside was 55 degrees when measured using the FDA-calibrated thermometer. Additionally, Messrs. Garcia, Rodriquez and Sabater stated that they maintained no thermometer calibration records.
4. You failed to have an individual who has successfully completed HACCP training, or who is otherwise qualified through job experience, develop a HACCP plan, reassess and modify the HACCP plan, and perform record review, as required by 21 CFR 123.10.
5. You must have and implement written verification procedures for ensuring that the fish and fishery products that you offer for import were processed in accordance with 21 CFR Part 123, and such procedures must list, at a minimum, product specifications and an affirmative step to comply with 21 CFR 123.12 (a)(2)(ii) . However, your firm did not have procedures Iisting product specifications or perform an affirmative step for anchovies manufactured by [redacted].
This letter may not include all deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the seafood HACCP regulations and the Good Manufacturing Practice regulations (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 steps to seize your products and/or enjoin your firm from operation. In addition, we may not provide certificates to your firm for export of your products to European Union (EU) countries if you do not correct these deviations.
Please notify this office in writing within 15 working days from your receipt of this letter of the specific steps you have taken to correct these violations including an explanation of each step taken to prevent their reoccurrence. Your response should include copies of any available documentation demonstrating that corrections have been made. If corrections cannot be completed within 15 working days, state the reason or the delay and the time frame within which the corrections will be completed.
Your reply relating to these concerns should be directed to the Food and Drug Administration, Attention: Virginia L. Meeks, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida 32751. If you have questions regarding any issue in this letter, please contact Ms. Meeks at (407) 475-4731. We look forward to working with you to achieve a successful HACCP program.
Emma R. Singleton
Director, Florida District