Dakota Laboratories, Llc – FDA Warning Letter, Jun 24, 2010

The FDA issued a Warning Letter to Dakota Laboratories, LLC, following a June 22-24, 2010, inspection of their pharmaceutical manufacturing facility. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Parts 210 and 211), rendering their drug products, including "(b)(4) Ear Drop" and "(b)(4) Pink Eye," adulterated. Additionally, these products were found to be misbranded under sections 503 and 301 of the Federal Food, Drug, and Cosmetic Act due to their labeling claims and failure to bear the "Rx only" symbol for prescription drugs.

Key violations include: 1. **Lack of sterile product procedures (21 CFR 211.113(b)):** Failure to adequately validate aseptic processes (e.g., media fills using incorrect bottle sizes) and establish specifications for sterilizing filters. 2. **Failure to establish time limits for production phases (21 CFR 211.111):** Inadequate justification for bulk product hold times and insufficient investigations into exceeded hold times. 3. **Inadequate investigations (21 CFR 211.192):** Failure to investigate environmental monitoring excursions in the aseptic suite and lack of microbial testing for water used in drug manufacturing. 4. **Inadequate environmental monitoring system (21 CFR