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EIR (Establishment Inspection Report) received by Sun Pharma for its Halol Facility in Gujarat

The Halol manufacturing Facility of Sun Pharma was inspected way back in September 2014 by three USFDA inspectors Parul Patel, Daniel Roberts and Thomas Arista who began inspection of the facility on September 8, 2014 which continued till September 19, 2014 leading to 23 observations and 19 page Form 483. The facility came under scanner as Sun Pharma made two major product recalls earlier that year which was significant as both the products were categorized under Class II which is considered serious as any exposure to the recalled product may cause temporary or medically reversible adverse health consequences.

Some of the discrepancies raised in the Form 483 included lapses in quality control procedures, inadequate root cause analysis of batch failures, lack of robust lab controls, documentation and computer control keeping practices, deficiencies in maintenance of equipment and hygiene of plants for which the company sent four updates to FDA in the year 2015 stating the corrective and preventive measures taken at Halol. US FDA however not being convinced with the responses issued warning letter to the company on 17th December 2015.

The warning letter came as a major setback for Sun Pharma as it had a very good track record of compliance in the past. Hence massive remediation plan was created for Halol facility which included training and retraining staff, hiring third party foreign consultants (for example, Jila Breeze was hired as head of global quality and compliance who had extensive experience of handing compliance and quality issues of Switzerland-based Novartis and Canadian drug maker Apotex) bringing in experienced hands from big pharma companies in the quality and compliance field like Davinder Singh, former Cipla technical director and veteran in the manufacturing space, to head manufacturing and VC Sehgal, chairman of Motherson Sumi Systems who has an enviable track record in quality standards in the auto industry as component supplier) and investing heavily on automation.

In December 2016, USFDA re-inspected the facility and issued nine 483 observations and maintained OAI (Official Action Indicated) status which is given when objectionable conditions are found and regulatory action is recommended. In February 2018, USFDA re-inspected the facility however three 483s were given with no data integrity issue and no repeat observations, following which it’s status was updated as VAI (Voluntary Action Indicated) status. It took almost 4 years which is quite a long time period for Sun Pharma to get out of FDA scanner and obtain EIR for its Halol facility.