FDA WARNING_LETTER - Eosera, Inc. - January 17, 2020

The FDA issued a Warning Letter to Eosera, Inc. following an inspection from January 13-17, 2020, identifying significant CGMP violations for finished pharmaceuticals, rendering their drug products adulterated. The firm manufactures OTC drug products "EAR PAIN MD," "EAR PAIN MD FOR KIDS," and "EAR ITCH MD," which are also cited as unapproved new drugs.

Key violations include: 1. **Inadequate OOS Investigations:** Failure to thoroughly investigate out-of-specification microbial test results for "EAR PAIN MD FOR KIDS" and "EAR PAIN MD" lots, including gram-negative rod contamination and *Burkholderia cepacia*. The firm failed to identify root causes, scope investigations adequately, and implement effective CAPAs. 2. **Deficient Stability Program:** The firm's stability program is inadequate, with unsupported expiry dates, unscientific pH specification changes, and recurring OOS assay results. 3. **Lack of Process Validation:** Failure to validate manufacturing processes for "EAR ITCH MD" and re-validate "EAR PAIN MD" after a facility relocation, indicating a lack of process control. 4. **Inadequate Quality Control Unit:** The Quality Unit lacks adequate procedures, documentation, and authority to ensure CGMP compliance.

The products "EAR PAIN MD," "EAR PAIN MD FOR KIDS," and "EAR ITCH MD" are deemed unapproved new drugs because their