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. The FDA frequently redacts portions of warning letters to protect companies.
Orchid Grocery
400 South Ave Ste 12
Middlesex, NJ, 08846-2567
In a July 16 warning letter the Food and Drug Administration outlined problems at the Orchid Grocery based on an inspection from May 22 through June 05, 2025. The FDA conducted a Foreign Supplier Verification Program (FSVP) inspection of the business. This inspection was conducted to determine compliance with the requirements of section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 384a) and the implementing FSVP regulation in 21 CFR part 1, subpart L.
The FSVP regulation requires that importers perform certain risk-based activities to verify that human and/or animal food they import into the United States has been produced in a manner that meets applicable U.S. food safety standards.
During the most recent inspection, the FDA found that the business is not in compliance with the requirements of 21 CFR part 1, subpart L for the foods it imports. At the conclusion of the inspection, FDA investigators provided company owners with a Form FDA 483a FSVP Observations. The FDA has not received a response to the Form FDA 483a issued on June 05, 2025.
Significant violations of the FSVP regulation are as follows:
The company did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR part 1.502(a). Specifically, it did not develop an FSVP for any of the foods you import including the following foods:
Natural Sesame Seeds from the foreign supplier (redacted) located in (redacted).
Dietary Supplement (redacted) from the foreign supplier (redacted) located in (redacted.
Fish Masala from the foreign supplier (redacted) located in (redacted).
The above violations are not intended to be an all-inclusive list of violations of the FSVP requirements. It is the company’s responsibility to ensure that it is in compliance with section 805 of the FD&C Act and the implementing regulation in 21 CFR part 1, subpart L.
This letter notifies the company owners of the FDA’s concerns and provides an opportunity to address them. If the company does not adequately address this matter, FDA may take further action. For instance, the agency may take action under section 801(a)(3) of the FD&C Act (21 U.S.C. 381(a)(3)) to refuse admission of the food the company imports for which it appears to be in violation of section 805. The FDA may place the foods you import into the United States from foreign suppliers on detention without physical examination (DWPE) when you import the foods.
The entire warning letter can be read here.
(To sign up for a free subscription to Food Safety News, click here)
