In September the US Food and Drug Administration (FDA) inspected two Mexican drug facilities over a three-week period. On March 9 both companies, Farma Quimia and Laboratorios Jaloma, were sent warning letters, with the former criticised for its API (active pharmaceutical ingredient) production.
“Neither your procedures nor your master batch production records require documentation of basic information such as the identity of manufacturing equipment used in the production of your API, sampling amounts…or the time the samples were taken”, the FDA wrote in its warning letter.
The FDA wrote it is “concerned with the lack of quality oversight” and inability to give inspectors files for sample preparation, analyst training, and other elements of GMP (good manufacturing practice).
Farma Quimia responded in October but the FDA wants more. In the warning letter the Agency calls on Farma Quimia to do a full review of the “adequacy” of its batch records and update its processes accordingly.
Last month the FDA placed Farma Quimia under import alert and the batch record update and other changes are needed to lift the ban. The FDA also calls on Farma Quimia to provide a schedule “for a robust equipment and instrumentation calibration programme”.
Lacking a lab
The FDA sent its other letter to a facility 500km west of the Farma Quimia plant. Laboratorios Jaloma received the warning letter after inspectors found it lacked the basics needed in a testing laboratory.
“Your firm does not have the equipment or standards necessary to perform all required testing, nor have you utilised a contract laboratory to conduct the tests you are unable to complete on site”, the FDA wrote.
The FDA also notes laboratory notebooks lacked data on weights, volumes, dates, signatures, the number of reagents used, and other pieces of required information. On March 9, the day of the warning letter, the FDA placed Laboratorios Jaloma under import alert.