FDA Warns Sun’s India Plant Over Sterility Concerns

Aseptic and sterility of serious violations, including water damage and leaks in parenteral manufacturing areas have been documented by the Food and Drug Administration (FDA) in the last warning letter to Sun Pharmaceutical manufacturing plant in Halol, India.

Since the inspection in September 2014, the FDA withheld approval of future products Halol plant.

The company was quoted in a warning letter separately in May 2014 on issues of integrity of data (records of good practice to manufacture garbage bags were found) in its manufacturing plant in Gujarat, India, which is also included in the import alert list of the FDA.

With regard to this last warning, Sun Pharma said it has already responded to comments "with a strong consolidation process is still ongoing, with major investments in automation and training to improve their quality systems."

The cover letter

FDA documents many infertility, particularly in the way in which the media recordings meet failed to include a specific description by Sun rejected bottles some batches.

"During the inspection, the Deputy Director General and the quality assurance (QA) manager confirmed that the discarded bottles were rejected during the filling process of the media without assignable causes recorded or documented," the FDA said.

In addition, the company did not make adequate ventilation studies to determine how the air movement and staff during aseptic operations pose a risk of infertility.

FDA asks Sun to perform a risk assessment for the practice of rejecting the means of filling bottles unlimited justification and acceptance in writing, as well as standard operating procedure revised media is filled, specifically relating to the amendments on the rejection and research of these non INTEGRAL bottles.

The company also failed to provide information on unknown impurities found within six months of accelerated stability test (for later distribution to US products), attributed to flaws in the product of degradation of the business process, but Sun It has not identified the specific impurities or its root causes.

In addition, Sun missing audit trails or other controls track people who access levels programmable logic controller or the man-machine interface equipment.

Water Leaks

An FDA investigators also documented water leaks, stains and damage in the ceiling area of ​​manufacturing parenteral personal broker. Buckets collecting water leaking from the ceiling in the manufacturing area were also found.

The FDA asked the company to address the "impact on the control environment since the beginning of flight and for the next six months. Include all cases that have been identified fungal or bacterial spores coaches, and also explain the extent that microbial identification were performed in these areas. "