HQ Team
February 24, 2023: The USFDA has closed an inspection of India’s Strides Pharma Science in southern Bangalore, which serves markets in the US, Europe and Australia, according to a BSE filing.
The Food and Drug Administration issued an Establishment Inspection Report after inspecting the facility between December 5 and 9 last year. Three inspectional observations were given to the company.
Based on the response, the US regulatory body has classified the inspection as Voluntary Action Indicated, and the establishment report stated the examination was closed.
Once the USFDA inspectors visit a plant, they clear it or issue Form 483 with their observations. Companies respond to queries raised by the regulator within a stipulated time frame.
The FDA issues the final classification of the site – which could be official action indicated, warning letter, voluntary action told or no action stated. If an OAI is issued, it means that based on the inspection, the facility is considered to be in an unacceptable state of compliance with current good manufacturing practices.
Import alert
An import alert may follow a warning letter or OAI classification if the regulator is not satisfied with the remedial action taken by the company.
A Voluntary Action Indicated (VAI) means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. Exports from a facility stop if placed under import alert.
Strides Pharma’s Bangalore facility is the largest manufacturing facility for the company, with the capability to produce finished dosage formulation products across multiple dosage formats, including tablets, capsules, ointments, creams, and liquids.
The company mainly operates in regulated markets and has an “in Africa for Africa” strategy and an institutional business to service donor‐funded markets.
Strides Pharma’s global manufacturing sites are located in India (Chennai, Puducherry, and two locations in Bengaluru), Singapore, Italy (Milan), Kenya (Nairobi), and the United States (New York).
The company focuses on “difficult to manufacture” products sold in over 100 countries.
