41-03
Adulterated and Misbranded Medical Foods
2 firms from 2 countries are named on this alert. Their shipments may be detained at the port without physical examination. The oldest listing here dates to 22 November 2010, the newest to 18 April 2014.
- 2firms listed
- 2countries
- 30 October 2024alert last published
- Source on FDA →accessdata.fda.gov
Why FDA issued it
In general, medical foods are analogous to infant formulas, in that the technology base is similar for the manufacture of both products. Adulterated medical foods may constitute short and long-term health hazards to the susceptible populations who consume these products. Potential health hazards associated with medical foods include compositional errors that result in microbiological and/or environment contamination. For this reason, the Center has identified medical foods as a high-risk food category. Therefore, the Agency is committed to assuring the continued safety and integrity of medical foods through annual inspection of all manufacturers of such products and routine analyses of medical food products. A firm may be listed on the Red List either because the most recent FDA inspection conducted at the plant revealed that the plant was not following 21 CFR 110 or was otherwise prepar
Quoted from the “Reason for Alert” section of the FDA page for 41-03, mirrored 30 August 2026. The quotation is truncated at the length this copy carries.
Firms named on 41-03
| Firm | Country | Listed since | |
|---|---|---|---|
| RUBIO DE B.C., S.A. DE C.V.CARRETERA A SAN LUIS KM. 7.5 S/N , Mexicali, Baja California MEXICO | Mexico | 18 Apr 201412 yr | |
| Sunspray Food Ingredients (Pty) Ltd92 Price Street , Johannesburg, Gauteng SOUTH AFRICA | South Africa | 22 Nov 201015 yr |