Delta Synthetic Co. Ltd. – FDA EIR, Oct 25, 2019

An FDA routine current Good Manufacturing Practices (CGMP) inspection of Delta Synthetic Co. Ltd., an Active Pharmaceutical Ingredient (API) manufacturer in New Taipei City, Taiwan, was conducted from October 21-25, 2019. The inspection, referencing Compliance Program 56002F and ICH Q7 guidelines, aimed to assess the firm's manufacturing of API products for the U.S. market, including Lidocaine HCl. A significant finding of this inspection was that no deficiencies were observed, and consequently, no Form FDA 483 (Inspectional Observations) was issued. The agency confirmed that all observations from a previous inspection in July 2018 were adequately addressed and corrected. These prior issues concerned inadequate maintenance and sanitization of the water system and a failure to collect representative water samples from points of use. Delta Synthetic Co. Ltd. had implemented comprehensive voluntary corrections. Discussions with management during the current inspection included an unresolved root cause for recurring out-of-specification events related to an unknown impurity in the Lidocaine HCl process, for which the firm committed to submitting a new test method to the FDA. Additionally, the firm immediately began drafting a new Standard Operating Procedure to formalize the cleaning and inspection of manufacturing tools and utensils.