Octapharma AB – FDA Warning Letter, Jan 20, 2011

The FDA issued a Warning Letter to Octapharma AB following an inspection from January 10-20, 2011, at their Stockholm, Sweden facility. The inspection revealed significant deviations from current Good Manufacturing Practice (CGMP) in the manufacture of Octagam® and Octagam intermediates, violating the FD&C Act, PHS Act, and 21 CFR Parts 210, 211, and 600-680.

Key violations include: 1. **Inadequate Process Validation (21 CFR 211.100):** The validation of the (b)(4) process for Octagam® was insufficient, with unaddressed clarity and IgA deviations during validation and subsequent manufacturing. Unvalidated process modifications were also made. 2. **Inadequate Investigations (21 CFR 211.192):** Failure to thoroughly investigate out-of-specification (OOS) results for clarity and measles, and manufacturing deviations for intermediate pastes from other facilities. Investigations for clarity OOS results were deemed inadequate, with lots released based on unapproved retesting. 3. **Release of Non-Conforming Products (21 CFR 211.165(f)):** Release of Octagam® lots (C005A845/U, C005B845/U, C008A8