Eugia Pharma Specialties’ manufacturing hub in India has received an FDA warning letter based on inspections of its facility.

The new warning letter is tied to previous warnings about the company’s Unit III Formulation manufacturing facility. The unit makes terminally sterilized products.

Eugia’s Hyderabad, India-based facility received an official action indicated (OAI) status notice in May, the company’s parent company, Aurobindo, said in a recent corporate filing.

An FDA OAI notice is an inspection classification that means the agency recommends regulatory or administrative actions. The designation can also cause approval or clearance delays. For the pharmaceutical industry, the FDA says an OAI classification can also indicate a facility is in an unacceptable state of compliance.

“The agency determines the final inspection classification by evaluating information collected during an inspection, as well as information provided by the facility following an inspection,” the FDA said on its website. “Inspection classification recommendations from investigators are an important factor in the evaluation and in the classification process. Additional information is considered to determine the final inspection classification, including the facility’s response to inspectional observations highlighted in Form FDA 483 and the company’s proposed or completed corrective actions.”

The company said in a corporate filing that there is no impact on the existing supply to the U.S. market and that Aurobindo Pharma is “commited to work closely” with the FDA and continues to enhance compliance on an ongoing basis.

The FDA’s Form 483 inspection findings and observations include:

• Procedures designed to prevent microbiological contamination of drug products purporting to be sterile were not established and followed.
• Laboratory records did not include complete data derived from all tests, exams and assays necessary for compliance with established specifications and standards.
• Batch production and control records did not include complete information relating to the production and control of each batch.
• Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process.
• There was a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications, whether or not the bath had already been distributed.
• Eugia did not establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are reported or represented to have.
• Appropriate controls over computers or related systems were not exercised to ensure that changes in master production and control records could only be made by authorized personnel.
• Changes to written procedures were not drafted, reviewed and approved by appropriate organizational units.
• Laboratory controls did not include establishing scientifically sound and appropriate test procedures to ensure drug products conform to appropriate standards of identity, strength, quality and purity.