The US FDA warning letter is issued to Indoco Remedies for its Oral Dosage Plant-1, Goa following an inspection in January 2019. The facility has classified as Official Action Indicated (OAI) in March 2019 after receiving Form 483 with 6 observations. The remediation activities for the observations is still going on in the facility.
The company is currently associated with a cGMP consultant to perform the remediation activities as per the expectations of the US FDA.
This facility of Indoco Remedies is having one approved ANDA and four pending ANDAs. Their approval may be withheld until the resolution of all these issues.
Mr Vinod Arora, Principal Advisor, IGMPI
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