FDA Issues Warning Letter to Absolutely Natural for CGMP Violations

The FDA inspected Absolutely Natural’s Melbourne facility in April 2025 and issued a Warning Letter in December 2025 citing significant violations of current good manufacturing practice (CGMP) for OTC products. Key deficiencies included:

1. Inadequate Out-of-Specification (OOS) Investigations – The company failed to thoroughly investigate microbiological deviations. For example, a July 2024 batch rejected for elevated bacterial counts and Pseudomonas aeruginosa was not adequately investigated. The FDA requires a comprehensive root cause analysis, retrospective review of all invalid OOS results, and a robust CAPA plan including monitoring of laboratory investigations, trend analysis, and improved investigation procedures.
2. Insufficient Validation of Microbiological Methods – Rapid microbiological testing methods lacked validation, could not produce quantitative data, and were not proven suitable for detecting Burkholderia cepacia complex. An independent review and full re-validation of laboratory methods is required.
3. Deficient Component Identity Checks – Identity and contamination testing of incoming high-risk components were inconsistent. Retroactive testing of materials already in use was not performed.

The FDA highlighted systemic deficiencies across OOS investigations, lab methods, CAPA management, and incoming goods inspections, demanding comprehensive, independent corrective measures to ensure product safety and compliance.

26-01-2026