The FDA slapped Foshan Flying Medical with a warning letter for inadequate testing, validation and training issues at its Guangdong, China, plant.
In the letter, dated Aug. 1 and posted on the agency’s website Wednesday, the FDA said its inspectors found numerous issues during an inspection in late February that included failures of adequate quality control over manufacturing and a lack of sterility testing.
Inspectors also said the company was unable to provide proper training documentation, and a senior manager said there had been no cGMP-related training for employees.
The company manufactures a variety of medical products including first aid kits, bandages and over-the-counter antiseptics, according to its website.
The FDA said Flying Medical also failed to retain batch records for its products for the requisite length of time.
As a result of the inspection, the agency placed Flying Medical on its import alert list May 23.