As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent.

Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.

Gourmet Catering to Go LLC — Nashville, TN
Stephen A. Simmons, president/owner

Live insects, evidence of rodents, mold and general filth are among the problems at an airline caterer, according to an FDA warning letter dated Feb. 3.

In the letter, agency officials told owner and president Stephen A. Simmons that his Gourmet Catering to Go LLC could be subject to closure and court action if problems at the company are not corrected. Inspectors found numerous “serious violations” of federal law during a visit to the facility from Sept. 27 to Oct. 17, 2019.

The warning letter did not state what airlines use the implicated catering company. The FDA has the policy of withholding the names of businesses customers, citing such material is “confidential corporate information.”

The FDA letter says ready-to-eat (RTE) foods at the facility, including salads, are adulterated, making it against the law to sell or serve them. The FDA’s inspection resulted in issuance of a Form-483 Inspectional Observations report, listing deviations found during the inspection. The agency acknowledged that the company owner had responded, but reported the response was inadequate to resolve the violations.

Specific problems cited in the letter included but are not limited to:

  • Failure to identify biological hazards such as E. coli O157:H7, Listeria monocytogenes, and Salmonella as known, or reasonably foreseeable hazards associated with raw ingredients to determine whether they are hazards requiring a preventive control.
  • The facility manufactures RTE food which is exposed to the environment prior to packaging. The packaged food does not receive a lethal treatment or otherwise include a control measure that would significantly minimize pathogens.
  • An employee was observed handling a trash can and then assembling RTE garden salads with the same gloved hands without changing gloves or washing and sanitizing hands.
  • An employee was observed handling raw salmon and then handling romaine lettuce for the RTE salads without changing gloves or washing and sanitizing hands.
  • White plastic bins where clean dishes are stored were observed to be soiled with food debris and one contained a dead fly.
  • Dirty dishes were observed stacked on a cart that also housed clean dishes and utensils.
  • A black mold-like substance was observed in an approximate 3-foot by 1-foot area above a small sink next to the dishwasher. This sink is located in the processing room and is used to rinse dishes and utensils before loading them into the dishwasher.
  • Dust build-up was observed on the refrigeration unit fan. This fan blows air directly onto uncovered fruits and vegetables.
  • A white mold-like build up was observed on several racks in the to-go cooler and kitchen storage areas. The to-go cooler is used to store food which has been prepared and is ready for delivery.Food wrappers, packaging material, dust and spider webs were observed under storage shelves and on the floor throughout the facility.
  • A white mold-like build up and old food debris were observed on the lower shelf of food preparation tables. These shelves are used to store various food ingredients.
  • Ceiling debris was observed on boxes of prepacked foods, food containers, and canned beverages, as well as food contact surfaces such as serving trays and ice buckets
  • Apparent rodent excreta pellets were observed in the storage area near food containers and lids along the side of the walk-in freezer.
  • House flies and fruit flies were observed throughout the facility. A fruit fly and house fly were observed on baked RTE brownies. A house fly was observed on lettuce used to make garden salads. A fruit fly was observed on a clean spatula and a house fly was observed on a knife used to prepare ready to eat foods.
  • Dead roaches were observed in the kitchen area along the wall across from the food prep tables near the roll-up delivery door, in the storage area next to boxes of packaged RTE snack food items, and in the men’s restroom.
  • A bucket of egg yolks was observed to have apparent red blood on the top of the lid that leaked from the raw meat stored above it in the cooler.
  • A mesh bag of potatoes was observed to be stored on the floor in the cooler.
  • Several boxes containing food and several single packages of food, including a bag of hummus, were observed directly on the floor in the freezer.

GuiLin SanYang Dietary Ecological Industry Co. Ltd. — China
Qin Hui Yue, President

A company in China is on notice from the FDA, risking having its products denied import into the United States, because of violations of U.S. food safety laws. The FDA inspected the company’s facility on Sept. 24, 2019.

The U.S. Food and Drug Administration (FDA) conducted an inspection September 24, 2019. 

“At the conclusion of the inspection, FDA investigators issued your facility an FDA Form-483 (FDA-483), lnspectional Observations, listing the violations found at your firm,” according to the warning letter. “We acknowledge your firm’s written response to the FDA-483, received on Oct.9, 2019, which included a description of corrective actions taken by your firm. Our review of your response determined that your firm has not adequately addressed all the violations related to your low-acid canned food (LACF) and acidified food (AF) products.”

Significant violations cited by the FDA included but were not limited to:

  • The firm did not have an accurate temperature-recording device and did not provide documentation demonstrating proper temperature documentation. 
  • The firm does not examine pouch container closures in appropriate detail to ensure proper closing machine performance and consistently reliable hermetic seal production.
  • The firm did not maintain processing and production records showing adherence to maintaining testing records for any batches of acidified vegetables, used as a component of rice noodle packets.
  • The firm did not mark each container with an identifying code, as required by U.S. law.
  • The firm limited access to what FDA investigators were able to observe within certain areas of your facility and would not allow investigators to take photographs.

“As a foreign food manufacturer exporting product to the United States, we remind you that FDA can inspect the facility at the time and in the manner, as permitted by the Food, Drug, and Cosmetic Act. Additionally, by submitting your Food Facility Registration with FDA, you acknowledge and permit FDA to conduct inspections, as described above,” according to the warning letter. 

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