AloeScience Labs, Inc. – FDA Warning Letter, Mar 9, 2012

The FDA inspected AloeScience Labs, Inc. from February 27 to March 9, 2012, identifying significant violations of dietary supplement Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 111), rendering their products adulterated under Section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Failure to establish product specifications:** No records for identity, purity, strength, and composition of finished dietary supplements (e.g., (b)(4)) or for components (e.g., Aloe, Grapeseed, Chamomile). The firm's response was inadequate as it did not commit to establishing specifications. 2. **Failure to verify identity of dietary ingredients:** No documentation of testing or examination results for dietary ingredient identities in finished batches (e.g., (b)(4)). The firm's response, citing supplier certificates and independent lab testing, was deemed insufficient without proof of implementation. 3. **Inadequate batch production records (BPRs):** Failure to document quality control approval/release or rejection of batches for distribution (e.g., (b)(4) lot # (b)(4)). The firm's response, citing a Vice President's authority and employee training, was inadequate as it did not commit specific quality control personnel or address the lack of a functional quality control unit. 4.