Granules Pharma US facility gets 6 observations from USFDA

New Delhi: Drug firm Granules India today announced that the US Food and Drug Administration (USFDA) has issued six observations after the inspection of the Chantilly facility of its US-based subsidiary. 

"The USFDA has completed an inspection of the facility of Granules Pharmaceuticals, Inc., a wholly-owned foreign subsidiary of the Company located in Chantilly, Virginia, the USA on 22nd July 2022 with six (6) observations," the company stated.

USFDA has completed an inspection of the facility of Granules Pharmaceuticals on 22nd July 2022.

"Granules Pharmaceuticals, Inc. will respond to these observations within the stipulated time period," the company added.

Read also: Granules Pharma clears USFDA audit

Medical Dialogues team had earlier reported that Granules Pharmaceuticals, Inc. located in Chantilly, Virginia, USA had received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA).

Read also: Granules Pharma clears USFDA Audit

Granules India is an Indian pharmaceutical manufacturing company that was founded in 1984 named as Triton Laboratories located in Hyderabad, India.

Granules manufactures varieties of drugs including Paracetamol, Ibuprofen, Metformin, and Guaifenesin, on a large scale for customers in the domestic as well as international markets.