FDA Issues Warning Letter to Canadian API Manufacturer

On July 24, 2018, FDA issued a warning letter to Les Produits Chimiques B.G.R., a Canadian API manufacturer, detailing violations of cGMP manufacturing standards at the company’s API manufacturing facility in Pointe-Claire, Quebec, based on an inspection conducted from Sept. 25–27, 2017.

During the inspection, FDA observed that the manufacturer failed to perform API testing to ensure that the material conformed to specifications and neglected to accurately document results on certificates of analysis. In addition, the company’s quality unit failed to exercise responsibility in ensuring that APIs manufactured at the facility complied with cGMP.

In response to the letter, the company is required to investigate and report the extent of inaccuracies in data records and the root causes of these data integrity lapses; a current risk assessment on API quality and patient risk; and a management strategy that details the company’s corrective action and preventive action plan (CAPA). The company must also provide CAPA plans and procedures that have already been implemented to ensure that the quality unit’s roles and responsibilities are clearly defined and established.

Further provisions in the response include revised documentation procedures for data recording, evidence that a stability chamber has been purchased and qualified and that the stability protocol has been updated, procedures detailing storage and inspection of raw materials, a report summarizing new cleaning validation studies, and revised cleaning procedures and checklists.

Source: FDA