The US Food and Drug Administration (FDA) has issued six observations for Piramal Pharma’s Turbhe facility. The facility is known for producing various pharmaceutical products, including generic drugs and active pharmaceutical ingredients (APIs). The observations were issued after an inspection conducted by the FDA from June to August 2022.
According to the FDA’s inspection report, the observations were categorized into two main areas: “Manufacturing Inspections” and “Packaging and Labeling”. The agency highlighted several issues that required immediate action, including:
1. Deviations in cleaning and sanitation: The FDA inspectors found that the facility’s cleaning and sanitation procedures were not consistently followed, which may potentially lead to product contamination.
2. Inadequate sampling and testing: The agency observed that the facility’s sampling and testing procedures for raw materials, in-process materials, and finished products were inadequate, which may impact product quality.
3. Incorrect labeling: The FDA found instances of incorrect labeling, as well as inadequate product labels for some products.
4. Improper storage and handling: The facility was not storing and handling products according to the recommended guidelines, which could lead to degradation or contamination of the products.
5. Inadequate training: The agency noted that the facility’s employees did not receive adequate training on good manufacturing practices (GMPs) and quality control procedures.
6. Inadequate quality control and assurance: The FDA inspectors found that the facility’s quality control and assurance procedures were not being followed, which may impact the quality of the products produced.
As a result of the observations, Piramal Pharma has been given a certain period of time to address the issues and correct the deviations. Failure to do so may result in further action by the FDA, including but not limited to, business suspension or product recall. It is essential for the company to take immediate and sustained corrective actions to ensure the production of high-quality products and maintain compliance with US FDA regulations.