Indoco Remedies
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).
Data sources that are checked in generation of this report
By purchasing this report you get access to a Pay as you go Monitor account which will allow you to select companies of your choice for reporting.
Recent Posts
- Stick and Carrot: Through Regulation or Choice, Change is Coming to Pharma Supply Chains
- Lessons from the pandemic: Life sciences supply chain vulnerability and the cost of resilience
- Sharing Insights on Supply Chain Risk: Intersys at BCI World 2021 Virtual Conference
- The Complex Truth Behind Vaccine Nationalism
- Who’s to Blame for the Vaccine Wars?
- More than Covid: Lessons for Supply Chain Resilience from 2020
- Analysis: Pharma Supply Chains and Covid-19 – The Story So Far
- Coronavirus puts a spotlight on business interruption exposures
- Coronavirus Drug Shortages Highlight Pharma Supply Chain Dependency on China and India
- The Real Reasons for UK Drug Shortages
- Draft Dodging: Pharma’s Escaping the US China Trade War for Now
- UK Medicines Shortages: Pharma Supply Chain Contagion More to Blame Than Brexit
- Regulatory Due Diligence Remains Key in Pharma M&A
- Regulatory Risks for Pharma in Brexit Uncertainty
- Intersys at Price Forbes Life Science Conference
- Can Pharmaceuticals Sit Out the US China Trade War?
- Is Brexit Bad for your Health?
- Brexit Scares Continue for the Pharma Supply Chain
- The New Challenges Around Drugs Shortages
- Impact of US China Tariff War- Intersys Provide Expert Opinion for Leading Pharma Publication
- Artificial Intelligence in Healthcare: Real Opportunities
- The blockchain supply chain in pharma
- New Business Interruption Insurance for Pharma
- Out and about at CPhI Worldwide
- Puerto Rico is hit again