Express Diagnostics International, Inc. – FDA Warning Letter, Jan 20, 2011

This FDA Warning Letter, dated March 23, 2011, addresses Express Diagnostics International, Inc. following an inspection from November 29, 2010, to January 20, 2011. The inspection found that the firm's DrugCheck® drug of abuse tests are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

Key violations include: 1. **Failure to establish adequate control over labeling activities (21 CFR 820.120):** Multiple product lots had finished product expiration dates that exceeded the expiration date of a key component ((b)(4)). The firm's responses were deemed inadequate, as it was unclear if the problem extended beyond the listed lots, and not all violative distributed product had been corrected or removed. 2. **Failure to establish adequate procedures for finished device acceptance (21 CFR 820.80(d)):** Device History Records (DHRs) for 12 lots of buprenorphine (BUP) test strips and 13 lots of alcohol test strips failed to demonstrate that products met specifications, specifically regarding testing with (b)(4). The firm's responses lacked sufficient information, an