Alkem Labs gets EIR from USFDA for St.Louis facility

"In furtherance to the intimation captioned "US FDA Inspection at Alkem's manufacturing facility located at St. Louis, USA" dated 23rd August, 2019, this is to inform you that USFDA has issued an Establishment Inspection Report (EIR) for the Company's manufacturing facility located at St. Louis, Fenton Logistics Park, USA," Alkem Labs said in a filing.

Mumbai: Drugmaker Alkem Laboratories (Alkem Labs) recently informed that the US health regulator has issued an Establishment Inspection Report (EIR) for its manufacturing facility at St. Louis, Fenton Logistics Park, USA.

The facility was inspected from August 16, 2019, to August 22, 2019, and where the Company received a Form 483 issued by the United States Food and Drug Administration (USFDA) containing four observations.

The inspection has now been closed by the USFDA. However, the drugmaker has been issued an EIR.

"In furtherance to the intimation captioned "US FDA Inspection at Alkem's manufacturing facility located at St. Louis, USA" dated 23rd August, 2019, this is to inform you that USFDA has issued an Establishment Inspection Report (EIR) for the Company's manufacturing facility located at St. Louis, Fenton Logistics Park, USA," Alkem Labs said in a filing.

Medical Dialogues had earlier reported that the Alkem Labs had received a Form 483 with four (4) observations for the facility located at St. Louis, Fenton Park, USA. Commenting on the observations, Alkem Labs had stated, "The Company shall put together a detailed response with adequate corrective and preventive measures to address the US FDA Observations for the facility located at St. Louis, Fenton Park, USA and the same is proposed to be filed within the timeline stipulated by US FDA."

Established in 1973, Alkem Laboratories has a portfolio of over 700 brands covering all major therapeutic segments. It has 16 manufacturing facilities, 14 being in India and two in the United States.

Read Also: Alkem Labs gets 4 USFDA observations for St Louis facility