FDA EIR - Ashland Specialty Ingredients - July 11, 2013

An FDA inspection of Ashland Specialty Ingredients, a manufacturer of active pharmaceutical ingredients (APIs), was conducted from July 9-11, 2013. The inspection, guided by Active Pharmaceutical Ingredient Process Inspection protocols, focused on Quality and Facilities & Equipment systems. Investigators identified significant issues, resulting in the issuance of an FDA Form 483. The primary violations included a failure to adequately investigate deviations. Specifically, the company did not conduct thorough investigations into out-of-trend microbiological results found in facility water, which exceeded established limits, nor did they investigate multiple instances of batch yield deviations for Allantoin that fell outside specifications. These omissions indicated a lapse in their quality control processes for identifying root causes and assessing product impact. Furthermore, the inspection revealed a lack of established written procedures to control access and manage changes within the laboratory's chromatography data system, which is critical for determining API purity. Both the Quality Systems Manager and a chemist had administrative access, raising data integrity concerns. In response to the observations, Ashland Specialty Ingredients committed to implementing corrections and submitting a formal written response within 15 days. Notably, during the inspection, the company voluntarily provided an approved procedure for data integrity and security for the chromatography system, addressing one of the identified shortcomings immediately.