New Delhi: Sun Pharma failed to properly clean and maintain equipment used for drug manufacturing at its Dadra-based manufacturing plant, according to the US Food and Drug Administration (USFDA).
In a warning letter sent to the company's managing director Dilip Shanghvi on June 18, the US health regulator stated that it inspected the plant in the union territory of Dadra and Nagar Haveli and Daman and Diu del December 4 to 15, 2023.
"Your company failed to clean, maintain and, as appropriate for the nature of the drug, disinfect and/or sterilize equipment and utensils at adequate intervals to prevent malfunctions or contamination that would alter the safety, identity, concentration, quality or purity . of the drug beyond official or other established requirements," the USFDA said.
The warning letter outlines significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceutical products at the facility, he stated.
The USFDA further noted that the company's investigations into out-of-specification (OOS) results were inadequate because they lacked scientific basis to determine the root cause.
"Your company did not fully 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 had already been distributed," he said.
A warning letter is issued when the US health regulator determines that a manufacturer has significantly violated its regulations.
The USFDA also cited similar CGMP violations at other company facilities.
"You committed to conducting a comprehensive assessment of your global manufacturing operations across your company network to ensure compliance with FDA requirements. These repeated failures at multiple sites demonstrate that management oversight and control over drug manufacturing are inadequate," the US health regulator said.
The important findings of this letter demonstrate that the pharmaceutical company does not operate an effective quality system in accordance with the CGMP, he added.
"We strongly recommend that your company hire a consultant to help you comply with the requirements of the CGMP," the USFDA stated.
It further said: "The FDA may withhold approval of new applications or supplements that list your company as a drug manufacturer until the deviations are fully addressed and we confirm your compliance with the CGMP. We may re-inspect to verify that you have completed the actions corrective action on any deviations," the USFDA said.
After the company receives this letter, respond to this office in writing within 15 business days, he said.
Specify what you have done to address any deviations and prevent them from recurring, he added.
The warning letter issued by the USFDA typically identifies the violation, such as poor manufacturing practices, problems with claims about what a product can do, or incorrect instructions for use.
The letter also makes clear that the company must correct the problem and provides instructions and a timeline of its plans for correction.
The USFDA then verifies that the company's corrections are appropriate.
In a warning letter sent to the company's managing director Dilip Shanghvi on June 18, the US health regulator stated that it inspected the plant in the union territory of Dadra and Nagar Haveli and Daman and Diu del December 4 to 15, 2023.
"Your company failed to clean, maintain and, as appropriate for the nature of the drug, disinfect and/or sterilize equipment and utensils at adequate intervals to prevent malfunctions or contamination that would alter the safety, identity, concentration, quality or purity . of the drug beyond official or other established requirements," the USFDA said.
The warning letter outlines significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceutical products at the facility, he stated.
The USFDA further noted that the company's investigations into out-of-specification (OOS) results were inadequate because they lacked scientific basis to determine the root cause.
"Your company did not fully 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 had already been distributed," he said.
A warning letter is issued when the US health regulator determines that a manufacturer has significantly violated its regulations.
The USFDA also cited similar CGMP violations at other company facilities.
"You committed to conducting a comprehensive assessment of your global manufacturing operations across your company network to ensure compliance with FDA requirements. These repeated failures at multiple sites demonstrate that management oversight and control over drug manufacturing are inadequate," the US health regulator said.
The important findings of this letter demonstrate that the pharmaceutical company does not operate an effective quality system in accordance with the CGMP, he added.
"We strongly recommend that your company hire a consultant to help you comply with the requirements of the CGMP," the USFDA stated.
It further said: "The FDA may withhold approval of new applications or supplements that list your company as a drug manufacturer until the deviations are fully addressed and we confirm your compliance with the CGMP. We may re-inspect to verify that you have completed the actions corrective action on any deviations," the USFDA said.
After the company receives this letter, respond to this office in writing within 15 business days, he said.
Specify what you have done to address any deviations and prevent them from recurring, he added.
The warning letter issued by the USFDA typically identifies the violation, such as poor manufacturing practices, problems with claims about what a product can do, or incorrect instructions for use.
The letter also makes clear that the company must correct the problem and provides instructions and a timeline of its plans for correction.
The USFDA then verifies that the company's corrections are appropriate.
