Indoco Remedies was issued with an FDA Warning Letter on 9 July 2019 following inspection of its facility in Goa, India which cited 3 violations for incomplete batch records, failure to investigate out of specification results and incomplete laboratory records, plus a recommendation to retain a qualified consultant for Data Integrity Remediation activities.
The same site also received a Warning Letter back in 2016 for inadequate complaints handling procedures and failure to follow quality control procedures.
They also had a run in with the EMA in 2018. For a full report, click Buy Report or or sign up for a free trial on Regulatory Incident Monitor (where you can build your own reports about the companies that interest you the most).
Published: July 30 2019
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