FDA EIR - Forest Pharmaceuticals, Inc - September 22, 2015

An FDA inspection was conducted at Forest Pharmaceuticals Inc. in Cincinnati, OH, on September 22, 2015. This focused inspection followed up on three significant product complaints submitted to the FDA, scrutinizing the company's complaint handling processes. The complaints involved Teflaro for injection, where a patient repeatedly observed dark particulate matter, and two separate Amour Thyroid complaints detailing patient adverse events, including severe reactions and side effects possibly related to product use following corporate acquisitions. Crucially, no new deficiencies were identified that merited an FDA-483 (Inspectional Observations) form. However, the inspection revealed that several of these critical complaints remained unresolved. For the Teflaro particulate complaint, the firm was still awaiting a product sample to finalize its investigation into potential product degradation. Similarly, for one Amour Thyroid adverse event, the investigation remained open as the company sought a sample from the complainant. The other Amour Thyroid complaint lacked sufficient information, like a lot number or sample, to conduct a full investigation. Operating under the regulatory framework for pharmaceutical complaint management, the FDA investigators reiterated the requirement for Forest Pharmaceuticals to meticulously review and handle all complaints and adverse events in accordance with established regulations. Although no formal corrective actions were mandated through an FDA-483, company management pledged to undertake further follow-up with the affected complainants to address the outstanding issues.