FDA EIR - HTL - March 07, 2013

An FDA inspection of HTL SAS, a French manufacturer specializing in Active Pharmaceutical Ingredients (API) like Sodium Hyaluronate for pharmaceutical and medical device applications, took place from February 25 to March 7, 2013. The regulatory oversight encompassed a CDRH Post Market Inspection for a device-related API and a CDER current Good Manufacturing Practice (cGMP) assignment for APIs, conducted under guidelines C.P. 7383.001A, C.P. 7356.002F, and CPGM 7356.002 for Drug Manufacturing Inspections. The inspection concluded favorably, with no FDA-483 (Inspectional Observations) issued, signifying an absence of significant deficiencies. However, minor issues were addressed directly with firm management during the closing meeting. Key observations included the need to establish reasonable timeframes within the Corrective and Preventive Action (CAPA) Standard Operating Procedure (SOP) (HP-QUA-006-09) and the supplier audit SOP (HP-QUA-002-04). Additionally, the inspection noted a lack of documented cleaning procedures for the HTL Fermentation area and sample preparation room. Management agreed to promptly update these SOPs to include the specified timelines and implement the necessary cleaning documentation. Furthermore, during the inspection, a previously unregistered contract laboratory associated with HTL SAS was successfully registered with the FDA.