FDA 483 - F.H. Investments Inc dba Asteria Health - December 05, 2025

During an inspection from December 5-19, 2025, the FDA identified significant manufacturing deficiencies at F.H. Investments, Inc., operating as Asteria Health, an outsourcing facility in Birmingham, AL. The firm failed to establish adequate written procedures for production and process controls, specifically lacking process validation for its implantable hormone pellets. This resulted in ongoing issues like metallic and foreign material contamination, multiple potency and process failures leading to rejected batches, and an absence of crucial sterilization, dissolution, and hardness/friability testing. The Quality Control unit exhibited severe shortcomings, including inadequate oversight of batch record changes, an ineffective visual inspection program, and a failure to properly investigate recurring contamination events. Furthermore, the firm lacked appropriate stability data to support product expiration dates, relying instead on non-representative legacy data. Aseptic processing areas were deficient, and laboratory records lacked complete data review. Critical data integrity issues were noted, with unrestricted access to analytical systems and inadequate control over batch records and equipment documentation. Batch production records were also incomplete, lacking documentation for metal detection testing. Asteria Health is required to address these violations, which indicate non-compliance with good manufacturing practices, to ensure the identity, strength, purity, and quality of its drug products.