USFDA inspected your drug manufacturing facility, Eugia Pharma Specialities Limited (Unit III), FEI 3008461619, at Plot No.: 4, 34 to 48, EPIP, TSIIC, IDA-Pashamylaram, Patancheru (Mandal), Sangareddy, Hyderabad, Telangana, from January 22 to February 2, 2024.
"You failed to ensure the accuracy of data in records for both production and process simulations (media fills)," USFDA noted.
Your operators also falsified environmental monitoring records for the ISO 5 and ISO 7 areas of multiple aseptic filling lines, including for viable active air samples and non-viable particle counts which were not collected in their documented location, it added.
The USFDA also stated that the company failed to prepare batch production and control records with complete information relating to the production and control of each batch of drug products produced.
"You failed to ensure records for equipment cleaning, disinfection, and sterilisation are complete and accurate," the latter noted.
According to PTI, Aurobindo Pharma spokesperson said, "There is no impact on the existing supplies to the US markets."
The company remains committed to work closely with the US FDA and continues to enhance its compliance on an ongoing basis, the spokesperson added.
According to USFDA, the company also failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes.
The warning letter summarises significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, it said.
A warning letter is issued when the US health regulator finds that a manufacturer has significantly violated its regulations.
USFDA sought a detailed corrective action plan that describes how the company intends to ensure the reliability and completeness of all the data generated including analytical data and manufacturing records.
The letter also sought a comprehensive description of the root causes of data integrity lapses including evidence that the scope and depth of the current action plan is commensurate with the findings of the investigation and risk assessment.
"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," USFDA said.
It further stated: "After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any deviations and to prevent their recurrence."
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 provide directions and a timeframe of its plans for correction.
FDA then checks to ensure that the company's corrections are adequate.
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