The US Food and Drug Administration (USFDA) has issued a warning letter to Eugia
Pharma Specialities, a subsidiary of Aurobindo Pharma that produces sterile injectables,
citing issues related to “data integrity” at its Unit-3 facility located in Pashamylaram, near
Hyderabad, Telangana.
The letter, dated August 15 and later disclosed by the USFDA, highlighted the company’s
failure to ensure the accuracy of data in records pertaining to both production processes and
process simulations, specifically media fills. Media fill is a microbiological test designed to
prevent contamination during the production of drugs.
The USFDA noted, “Your procedure mandates the testing of all [redacted]. Although your
documentation indicates that all [redacted] were tested, your operators did not actually test all
[redacted] utilized during the manufacturing of sterile injectable drug products.”
The USFDA also highlighted that operators had falsified environmental monitoring records
across multiple aseptic filling lines. “These widespread data integrity issues involved
numerous personnel in both production and quality assurance and persisted at your facility
over several months,” the letter stated.
