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Inspection History

Pii’s facilities are regularly audited by customers and regulatory bodies. On average, Pii completes more than 50 quality audits per year.  Pii views regulatory inspections as an opportunity to learn and continually improve our quality systems. As a result of our strong compliance record, Pii has successfully completed more than 30 pre-approval inspections (PAI) for our client’s products.  Regulatory inspection agencies who have audited Pii’s facilities include:

 

  • Food and Drug Administration (FDA)

  • European Medicines Agency (EMA)

  • UK Medicines and Healthcare Products Regulatory Agency (MHRA)

  • Korea Food & Drug Administration

 

We are proud of the success Pii has achieved over the years in maintaining our status as a compliant manufacturer. Yet we remain steadfast in our commitment to quality and continue to work diligently to exceed current expectations.

 

2017 - MHRA/FDA

2016 - FDA/MHRA

2015 - EMA/MHRA

 2014 - FDA

2013 - FDA/EMA