Auxigen Pharmaceutical, LLC – FDA Warning Letter, Jul 8, 2014

An FDA inspection of American Family Pharmacy, LLC, from June 11 to July 8, 2014, revealed significant violations of current good manufacturing practice (CGMP) regulations (21 CFR Parts 210 and 211), causing drug products to be adulterated under Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act. The firm also failed to fulfill registration and listing obligations under Section 510, leading to misbranded drugs under Sections 301(p) and 502(o), 502(a), and 502(f)(2) of the Act.

Specific violations include: 1. **Failure to follow quality control unit procedures (21 CFR 211.22(d)):** The firm used single lot numbers for multiple batches of aspirin and acetaminophen, preventing differentiation and distributing products without quality unit review. 2. **Lack of finished product testing (21 CFR 211.165(a)):** Multiple lots of 81 mg aspirin tablets were distributed without required finished product testing. FDA testing of lot 12084 aspirin tablets found failures in assay, content uniformity, and dissolution, leading to a voluntary recall. Inconsistent tablet color and uninvestigated customer complaints were also noted. 3. **Inadequate procedures for components and containers (