FDA Warns Mexican OTC Drugmaker, Dutch Drugmaker, San Francisco Device Company
The US Food and Drug Administration (FDA) on Tuesday released warning letters sent recently to Jalisco, Mexico-based over-the-counter (OTC) drugmaker Jabones Y Productos Especializados, Netherlands-based drugmaker Fagron BV’s Minnesota manufacturing site and San Francisco-based ITG-MEDEV, Inc.Jabones Y Productos Especializados
The company was cited by FDA for four violations following a three-day inspection in March. Among the violations was the company’s failure to perform any final product testing on the identity and strength for certain OTC drug products.
Jabones also failed to verify the identity of each component of its drug products, with FDA noting, “You failed to test the incoming active pharmaceutical ingredient (API) and other raw materials you use in manufacturing your drug product to determine conformance to identity, purity, strength, and other appropriate specifications.
Instead, your firm released API and other materials based on certificates of analysis (COA) from your supplier without establishing the reliability of the supplier’s analysis through appropriate validation and ensuring at least one specific identity test is conducted for each lot.”
The firm was also found to lack an adequate process validation program.
Fagron BV
The Dutch company’s Minnesota-based site was inspected over the course of a month in November and December 2017 and was warned for multiple violations, including a failure to transfer all quality or regulatory information received from an API manufacturer.
“Your quality unit omitted the names and addresses of the original manufacturers of your repackaged API on certificates of analysis (COA) you issued to your customers, and did not always include copies of original batch certificates,” FDA said.
The agency also called the company out for lacking adequate procedures to maintain control over previously recalled estriol lots, while the firm’s drug product stability testing procedure did not define drug product storage requirements.
ITG-MEDEV, Inc
The San Francisco-based manufacturer of a wound dressing product, following a five-day inspection in June, was found to have failed to ensure its contract sterilizer performs properly.
“You stated to our investigator your new contract sterilizer is not able to perform the validation studies to ensure with a high degree of assurance that its process will consistently meet your specification,” FDA said.
The company was also found to not document corrective and preventive action (CAPA) activities in response to nonconforming product.