The Food and Drug Administration recently made public two warning letters issued in November 2018 involving significant violations of federal law. Violators have 15 working days to respond in writing. The FDA has not issued closeout letters for either of the companies reported below.

Gonzalez and Nietos LLC — formerly Loty International Wholesalers Corp. Miami, FL
In an “amended warning letter” dated Nov. 29, 2018, and sent to company owner and manager Andrew Gonzalez, FDA officials cited serious violations including cockroaches in the facility and packaging issues that mean the growth of Clostridium botulinum, which produces the toxin that causes botulism poisoning, is “reasonably likely to occur.”  

“… we have not received your firm’s written response, describing proposed corrective actions, the status of promised corrective actions, or how corrective actions you have taken will be sustained to prevent recurrence, to address the observations noted on the FDA-483, Inspectional Observations (form issued in May 2018),” according to the amended letter. 

“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.”

An FDA inspection of the company’s food storage and distribution facility on May 17 and 17, 2018, and found a serious violation of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation. The inspection also revealed a serious violation of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food regulation.

based on FDA’s findings during the inspection, the company’s seafood products, such as salted herring and pollack, and other food products stored at the facility are adulterated, in that they have been prepared, packed or held under insanitary conditions wherby may have been rendered injurious to health.

At the conclusion of the May 2018 inspection, the federal agency issued an FDA-483 Inspectional Observations form, listing the deviations found at the facility. As of its November 2018 amended warning letter, FDA had not received the firm’s response to the FDA-483.

Significant violations discussed in the amended letter included:

• The firm does not have a HACCP plan for refrigerated salted herring products to control the food safety hazard of scombrotoxin (histamine) formation.
• Refrigerated salted boneless pollack products appeared to be received in reduced oxygen packaging, which means Clostridium botulinum growth and toxin formation are reasonably likely to occur.
• The company had not taken adequate measures exclude pests from its facility, with inspectors finding live and dead cockroaches in several areas, as well as a birds’ nest in the building and bird excreta on several boxes of “Loty Chicken Flavor Bouillon.” 

“A powder, identified by your firm as a mix of corn flour and ground-up rodent bait blocks, (was found) throughout your entire facility along the walls, and in between racking systems of stored packaged food products. The bait was identified to be ‘Bell Contrac All Weather Blox’ used to kill rats, mice and meadow voles,” according to the amended warning letter.

H & H Products Co. Orlando, FL
In a warning letter dated Nov. 15, 2018, the FDA informed company president Morris L. Hartley Jr. of repeat violations related to its juice and syrup products.

“Please be aware that your firm was issued an Untitled Letter dated Oct. 1, 2007; and a Warning Letter (WL) re: FLA-09-15 dated May 5, 2009,” according to the November 2018 letter. “In addition, a Regulatory Meeting was held with your firm on March 22, 2011.”

The FDA conducted an inspection of the company’s food processing facility from July 17-20, 2018. The inspectors found the business has serious repeat violations of federal regulations regarding Juice Hazard Analysis and Critical Control Point (HACCP) plans, as well as problems with pH levels and labeling on pancake syrups.

The warning letter from November 2018 states that the H & H juice concentrate products and acidified food products are adulterated in that they have been prepared, packed, or held under insanitary conditions wherby they may have become contaminated with filth, or wherby they may have been rendered injurious to health.

“We acknowledge receipt of your firm’s written response dated Aug. 2, 2018, to the observations noted in the Form FDA 483. We address each response below in relation to each of the noted violations,” according to the 

Juice HACCP violations at H & H
The HACCP plan for H & H “Products With Concentrated Juices,” which covers all of the company’s single strength 100 percent juices, including: Ascend brand 100 percent lemon juice, 100 percent lime juice, and 100 percent key lime juice; as well as your Florida Key West brand 100 percent lemon juice and 100 percent key lime juice, fails to list measures that would bring about a 5-log pathogen reduction in the pertinent microorganism. This is a repeat observation from an “Untitled Letter” dated Oct. 1, 2007, a “Warning Letter” dated May 5, 2009, and FDA inspections conducted in 2011 and 2018.

“We have reviewed your written response to Form FDA 483 dated Aug. 2, 2018,” according to the FDA’s Nov. 15, 2018 warning letter. “Your response is inadequate. You did not provide evidence to document how you will avoid introducing single strength juice into commerce that has not undergone a 5-log pathogen reduction process; thus, we are unable to determine the adequacy of your corrective actions.”

You do not conduct a 5-log pathogen reduction process for any of your single strength juices, including: Ascend brand 100 percent lemon juice, 100 percent lime juice, and 100 percent key lime juice; and Florida Key West brand 100 percent lemon juice and 100 percent key lime juice.

“We have reviewed your written response to Form FDA 483 dated Aug. 2, 2018,” according to the Nov. 15, 2018 warning letter. Your response is inadequate.”

The FDA warning letter states H & H did not did not explain how it will avoid introducing single strength juice into commerce that is not covered under a HACCP Plan that includes control measures that will consistently produce a 5-log pathogen reduction prior to implementing a new HACCP Plan, “thus, we are unable to determine the adequacy of your corrective actions.”

Acidified foods violations at H & H
The response from H & H regarding violations in its pancake syrup operations are also inadequate, according to the FDA’s November 2018 warning letter.

“You must mark each container with an identifying code specifying the establishment wher the product was packed and the product contained therein,” according to the most recent warning letter.

“On July 19, 2018, our investigator observed the 1-ounce portion cup containers for your Hartley’s brand ‘Sugar Free Pancake & Waffle Syrup,’ which is an acidified food, are not marked/identified with any code. Also, the identifying code on 12-ounce containers for your Hartley’s brand ‘Sugar Free Pancake & Waffle Syrup’ does not specify the establishment wher the product was packed, the product contained therein, and the packing period. The bottles are only coded with a production date and best-by date.

“We have reviewed your written response to Form FDA 483 dated Aug. 2, 2018. Your response is inadequate. You did not provide details, nor documentation evidence on how you plan on accomplishing the coding process for your 1 oz. cups and you did not explain how you will avoid introducing acidified foods into commerce which either lack an identifying code (1 oz. cups) or do not contain all the required code elements (12 oz. bottles) prior to implementing the new processes.”

The FDA also informed the company president that his written response to the agency’s Form FDA 483 dated Aug. 2, 2018, neither mentioned nor provided any evidence of an internal investigation and/or consultation with a process authority regarding a pH deviation of some Hartley’s brand Sugar Free Pancake & Waffle Syrup that H & H shipped into commerce after recording a final pH of 4.58, deviating from their maximum equilibrium pH of 4.50.

The FDA’s Nov. 15, 2018, warning letter says H & H did appropriately respond regarding three problems listed on the Form FDA 483 dated Aug. 2, 2018. “We will verify the adequacy of your proposed corrective action during our next inspection,” according to FDA’s most recent letter.