FDA WARNING_LETTER - Absolutely Natural - April 24, 2025

The FDA issued a Warning Letter to Absolutely Natural following an inspection of its Melbourne facility from April 22 to 24, 2025. The agency identified significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, leading to the classification of the company"s over-the-counter drug products as adulterated.

Key issues included a failure to thoroughly investigate unexplained discrepancies and out-of-specification (OOS) results. Specifically, the company did not adequately investigate a July 2024 batch failure caused by microbiological contamination, including Pseudomonas aeruginosa, lacking a proper root cause analysis and failing to assess other potentially affected batches. The FDA found the company"s initial response insufficient, noting a lack of detail regarding affected products and a retrospective OOS review.

Furthermore, Absolutely Natural failed to adequately validate its alternative rapid microbiological test methods, such as the (b)(4) system, used for finished drug products. These methods lacked proper quantification, identification of objectionable microorganisms, and failed to demonstrate sufficient capability for detecting Burkholderia cepacia complex. Validation studies also deviated from compendial methods without scientific justification, and the company did not verify the manufacturer"s validation.

To address these issues, the FDA requires Absolutely Natural to conduct a retrospective, independent review of all invalidated OOS results, comprehensively remediate its OOS investigation and CAPA programs, and provide a detailed action plan to improve its overall investigation system. The company must also establish and document the accuracy and suitability of its test methods through proper validation.