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US FDA Issued Form 483 to Alkem Laboratories Ltd. After Inspection of Its St Louis-based Formulation Plant

An FDA Form 483 is issued to a firm management at the conclusion of an inspection when an investigator has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic Act and related Acts.

Alkem Laboratories Ltd., incorporated in the year 1973, is a Large Cap company (having a market cap of Rs 37,343.74 Crore) operating in Pharmaceuticals sector.

Alkem Laboratories Limited is an Indian multinational pharmaceutical company headquartered in Mumbai, Maharashtra, India that manufactures and sells pharmaceutical generics, formulations and nutraceuticals in India and globally.

Alkem set up its innovative work office for ANDA improvement at Taloja in 2003. In 2006 enemy of infective medication Taxim of Alkem turned into the principal hostile to infective medication in the Indian drug industry to cross 1,000 million as far as homegrown deals in India. In 2014 Clavam other medication from Alkem crossed 2,000 million imprint as far as homegrown deals in India. In 2007 the organization recorded its first ANDA for drug Amlodipine which was endorsed in 2009. Alkem has fostered an arrangement of 705 marked conventional medications, with 13 of the brands included among the main 300 brands in India for the monetary year 2015 and an arrangement of 705 brands in India in the a half year finished 30 September 2015. Alkem have 21 assembling offices, 19 in India and 2 in US. 5 of the offices are US FDA, TGA, UK MHRA supported.

As on today, Alkem has :


  • 21 Manufacturing units
  • Over 800 brands
  • Business footprint in over 50 countries
  • A 14,500 plus strong workforce
  • Multiple acquisitions and joint ventures
  • Consolidated revenue at Rs. 83,444 million in FY2019-20
Alkem, which has operations spread across multiple territories abroad, produces a complete range of formulations of controlled substances at its finished dosage manufacturing facility in St Louis, Missouri. The US-FDA had conducted an inspection of the company’s manufacturing plant at St Louis, USA from June 14-18, 2021.
At the end of the investigation, the company received Form 483 with two observations from the US-FDA. It notifies the company’s management of objectionable conditions at the facility.
A FDA Form 483 is given to a firm administration at the end of an inspection when an US FDA auditor has noticed any conditions that in their judgment may establish infringement of the Food Drug and Cosmetic Act and related Acts.
The company shall submit to USFDA within the stipulated timeline, a detailed response to close out all the observations associated with this inspection.

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