A company in China is on notice from the FDA for lacking hazard analysis on certain items. In a July 7 warning letter, the FDA described a Dec. 1-3, 2020, inspection of Panjin Hetian Food Co. Ltd. in Liaoning, China.

The FDA’s inspection revealed that the firm was not in compliance with the Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, part 117 (21 CFR part 117) and resulted in the issuance of an FDA Form 483. The significant violations are as follows:

The firm’s hazard analysis for ready-to-eat (RTE) rice protein powder manufactured/processed at their facility did not identify and evaluate all known or reasonably foreseeable hazards to determine whether there are any hazards requiring a preventive control. Specifically:

They did not identify contamination with environmental pathogens, such as Salmonella, as a known or reasonably foreseeable hazard to determine whether it requires a preventive control for RTE rice protein powder. A hazard evaluation must include an evaluation of environmental pathogens whenever a RTE food is exposed to the environment prior to packaging and the packaged food does not receive a treatment or otherwise include a control measure. The firm’s facility manufactures rice protein, a RTE food which is exposed to the environment after a (redacted) treatment prior to packaging. once packaged, the food does not receive a lethal treatment or otherwise include a control measure (such as a formulation lethal to the pathogen or control by the supply chain or a downstream customer) that would significantly minimize the pathogen. In particular, the firm manufactures rice into a rice protein powder that is exposed to the environment at the (redacted) steps. This exposure presents the potential for the rice protein powder to be contaminated with environmental pathogens, which can enter the facility in several ways, including on raw materials.

Note that if environmental pathogens are a hazard requiring a preventive control such as sanitation controls, the controls must be verified by environmental monitoring such as for environmental pathogens or an appropriate indicator organism. Also note that their environmental monitoring procedures are inadequate to identify the presence of environmental pathogens or an appropriate indicator organism because TPC and coliforms are not indicator organisms for environmental pathogens.

The cleaning of food-contact surfaces at the ball grinding, vibrating, and packaging machines involves a cold water wash without detergent, followed by air drying. The firm response indicates that their “(redacted)” has been revised to include a colorless and odorless detergent when cleaning the ball grinders. However, it is not clear what equipment is included within the scope of their procedure or whether food-contact surfaces are sanitized after being cleaned. Water in a dry processing environment presents a significant risk factor for Salmonella contamination because water allows for pathogen growth, significantly increasing the risk for contamination of RTE food. Dry cleaning techniques such as wiping, scraping, sweeping, brushing, vacuuming, blowing, etc. are preferable. wher dry cleaning of equipment and facilities is not possible, and wet cleaning is deemed essential due to a product contamination incident or elimination of allergens, care should be taken to minimize spread and ingress of water throughout the facility. When wet cleaning is used, it should be carefully controlled, and should include use of a sanitizer. Water usage should be limited to an absolute minimum and confined to a specific area, and thorough drying is essential to minimize growth of Salmonella which may be in the environment.

Guillermo Osuna
San Diego, CA

An import company in San Diego is on notice from the FDA for not having FSVPs for a number of imported food products.

In a June 25 warning letter, the FDA described a Feb. 23, 2021, through March 1, 2021, remote Foreign Supplier Verification Program (FSVP) inspection of Guillermo Osuna in San Diego, CA.

The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations and resulted in the issuance of an FDA Form 483a.

The significant violations are as follows:

The firm did not develop, maintain, and follow an FSVP as required. Specifically, their firm did not develop an FSVP for each of the following foods:

1. Cucumber-lemon bottled water imported from Envasadora La Suprema SA de CV located in Mexico
2. Hibiscus-Jamaica bottled water imported from Envasadora La Suprema SA de CV located in Mexico
3. Lychee bottled water imported from Envasadora La Suprema SA de CV located in Mexico

Dry Produce Division USA LLC
McAllen, TX

An import company in Texas is on notice from the FDA for not having FSVPs for a number of imported food products.

In a June 30 warning letter, the FDA described a March 24-26, 2021, remote Foreign Supplier Verification Program (FSVP) inspection of Dry Produce Division USA LLC at McAllen, TX. 

The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations and resulted in the issuance of an FDA Form 483a. The significant violations are as follows:

The firm did not develop, maintain, and follow an FSVP as required. Specifically, they did not develop, maintain, and follow an FSVP for any of the foods their import including each of the following food products:

• Dried Guajillo chili peppers imported from Distribuidora de Productos Deshidratados located in Zacatecas, Mexico.
• Pumpkin seeds (roasted and salted) imported from Distribuidora de Productos Deshidratados located in Zacatecas, Mexico.
• Dried Chickpea Beans from Distribuidora de Productos Deshidratados located in Nuevo Leon, Mexico.