FDA WARNING_LETTER - Rajshree International, Inc. - March 06, 2020

On May 4, 2020, the FDA issued a Warning Letter to Rajshree International Inc. following Foreign Supplier Verification Program (FSVP) inspections on March 6, 2020, and September 10, 2018. The inspections found the company non-compliant with 21 CFR part 1 subpart L and section 805 of the FD&C Act for imported Ying Yaang Hakka Noodles from Frumar Marketing Pvt. Ltd., India, and Lays Magic Masala from Pepsico India Holdings Pvt. Ltd., India.

The primary violation was the failure to develop, maintain, and follow an FSVP as required by 21 CFR 1.502(a). The company did not respond to Form FDA 483a observations issued after both inspections.

Additionally, Rajshree International Inc. failed to renew its food facility registration for 12020 Woodruff Ave, Ste F, Downey, CA 90241, as required by section 415(a)(3) of the FD&C Act and 21 CFR Part 1, Subpart H. This constitutes a prohibited act under section 301(dd) of the FD&C Act.

The FDA requires the company to correct these violations promptly. Failure to do so may result in refusal of admission for imported food products under section 801