“Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitise and/or sterilise equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements,” the USFDA said.
The warning letter summarises significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals at the facility, it stated.
USFDA further noted that the company’s investigations of out-of-specification (OOS) results were inadequate because they lacked scientific rationale for root cause determinations.
“Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed,” it stated.
A warning letter is issued when the US health regulator finds that a manufacturer has significantly violated its regulations. The USFDA also cited similar CGMP violations at company’s other facilities. “You committed to conduct a comprehensive assessment of your global manufacturing operations across your company’s network to ensure conformance to FDA requirements. These repeated failures at multiple sites demonstrate that management oversight and control over the manufacture of drugs is inadequate,” the US health regulator stated.
Significant findings in this letter demonstrate that the drug firm does not operate an effective quality system in accord with CGMP, it added.
“We strongly recommend that your firm engage a consultant to assist your firm in meeting CGMP requirements,” USFDA stated.
It further said, “FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any deviations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to any deviations,” the USFDA said.
After the company receives this letter, respond to this office in writing within 15 working days, it said.
Specify what you have done to address any deviations and to prevent their recurrence, it added.
The warning letter issued by the USFDA usually identifies the violation, such as poor manufacturing practices, problems with claims for what a product can do, or incorrect directions for use.
The letter also makes clear that the company must correct the problem and provides directions and a timeframe of its plans for correction.
USFDA then checks to ensure that the company’s corrections are adequate.
