Granules India’s Gagilapur unit gets 6 observations from USFDA

12 Sep 2024 , 03:26 PM

The US Food and Drug Administration (USFDA) issued six observations to Granules India’s Gagillapur factory in Hyderabad, Telangana, following an inspection conducted from August 26 to September 6.

The regulator stated that the main breaches identified were as follows: 

1. Equipment and utensils are not cleaned at proper intervals.
2. Failure to thoroughly investigate any unexplained discrepancies.
3. In observation number two, the USFDA notes a repeat observation from January 2023.
4. Responsibilities and procedures related to the quality control unit are not in writing but are thoroughly implemented.
5. The process of materials widely used in everyday manufacturing has not been fully assessed.
6. The written processes are not followed.
7. The building and its facilities are not maintained.

 

Granules India told investors in a statement that they are actively responding to the remarks and are fully dedicated to resolving the issues identified. “We will work with the USFDA to address the issues raised in the observations.”

Granules prioritises quality and compliance, and these concepts are deeply established in its ongoing review and governance systems, according to the company. 

The USFDA has also noted a repeat observation from the company’s January 2023 inspection. The inspection also discovered severe flaws, such as microbial contamination in the Air Purification Unit, which included several fungal and bacterial colonies.

Observers noted the disposal of junk materials, including GMP records, which analysts believe could indicate data integrity issues. The form 483 also noted bird droppings and feathers on the Air Purification Units, as well as worries about the water tank, which had not been cleaned since its installation and was in bad condition.

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