FDA EIR - Zeco LLC - March 15, 2019

An FDA inspection of DeLaval Manufacturing in Grand Prairie, TX, was conducted from March 7-15, 2019. This routine inspection assessed the company's compliance with 21 CFR 211, the Current Good Manufacturing Practice for Finished Pharmaceuticals, as an Over-the-Counter (OTC) Animal Drug Manufacturer. The primary violation, documented on a Form FDA 483, was the deficiency in complaint records, specifically that investigation findings and follow-up were not included. This was a repeat observation from a previous inspection. Additionally, the inspector noted several other issues during discussions with management, including the lack of documentation for facility cleaning and storage equipment temperature monitoring, and the absence of maintenance logs for production and storage equipment. Batch records also showed problems such as missing lot numbers, initials, dates, and a lack of independent review for product release, as a single employee conducted both testing and final approval. Furthermore, several procedures were in use without proper approval signatures. DeLaval was advised to voluntarily correct these conditions. Management was informed that failure to do so could lead to regulatory actions, including a warning letter or seizure. The company is required to submit an electronic response to the FDA within 15 business days, outlining their corrective actions. Management acknowledged the findings and indicated steps were already underway to address the issues, such as developing new documentation forms and revising batch record review processes.