FDA WARNING_LETTER - American Pecan Co. LLC - February 10, 2010

From January 11 to February 10, 2010, an FDA inspection of American Pecan Co. LLC's pecan repackaging facility in Yancey, Texas, revealed significant violations. The facility processes ready-to-eat, raw pecans.

A product sample (Pecan Pieces, Medium) was found to be contaminated with *Salmonella oranienburg*, rendering the product adulterated under 21 U.S.C. 342(a)(1). The firm initiated a recall on February 26, 2010.

Environmental samples from the facility tested positive for *Salmonella spp.*, with six subsamples identified as *Salmonella newport* and one as *Salmonella oranienburg*. PFGE testing indicated *Salmonella* may have established a niche, leading to adulteration under 21 U.S.C. 342(a)(4) due to insanitary conditions. Specifically, painted plywood floors in processing areas, which are not easily cleanable, were identified as a source of *Salmonella newport*.

Additionally, several products were misbranded under 21 U.S.C. 343. Bulk pecan products lacked a statement of identity (21 CFR 101.3(a)), and several pecan products failed to bear a Nutrition Facts panel (21 CFR 101.9). The firm had not filed