Deltex Pharmaceuticals Inc – FDA Warning Letter, Jul 15, 2008

An FDA inspection of Deltex Pharmaceuticals Inc. (June 9 - July 15, 2008) revealed significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated under 21 U.S.C. § 351(a)(2)(B). The firm also markets unapproved new drugs, violating 21 U.S.C. § 355(a), and misbranded drugs under 21 U.S.C. §§ 352(f)(1) and 352(c).

Key violations include: 1. **Quality Control Unit Deficiencies (21 CFR § 211.22(d)):** Failure to follow SOPs for spectrometer and balance calibration, and an inadequate Out-of-Specification (OOS) investigation procedure. 2. **Inadequate Laboratory Controls for Components (21 CFR § 211.160(b)(1)):** FT-IR identity testing for tannate APIs was insufficient to detect physico-chemical changes or distinguish between compounds. 3. **Lack of Scientifically Sound Specifications (21 CFR § 211.160(b)):** No specifications for free Tannic Acid, certain bulk ingredients, or dissolution/drug release for tannate products. 4. **Insufficient Microbiological Testing (21 CFR § 21