This Hyderabad, India-based API-maker earned both a warning letter and an import alert. Warning Letter 320-11-20 cites 5 counts of GMP violations, from a lack of documentation to inadequate facilities.
"Your firm's broad-based CGMP compliance issues will require significant remediation and substantial investment of time and resources," the letter says. "Until such time as your manufacturing practices are verified to comply with CGMPs, your firm will remain under FDA Import Alert and FDA will continue to refuse admission" of all Yag-Mag products.
Inspectors discovered nearly a year's worth of batch records that were generated months after products were manufactured and shipped. "Backdating of records is not an acceptable practice," the warning says. "This finding that manufacturing batch records are untrustworthy represents a basic systemic failure by your company."
On the facilities end, inspectors found that the plant design neither facilitated cleaning nor minimized the potential for contamination. They discovered residues and corrosion on processing equipment, while materials and equipment were exposed to outside elements unprotected. In addition, a pipe was leaking and a recessed ground-level floor, susceptible to flooding, contained standing water.
"We highly recommend that you hire a third party auditor with experience in detecting data integrity problems, who may assist you in evaluating your serious CGMP deviations" the letter says.