Reason for 483 observation issued: Deviation from manufacturing standard
About Plant: The Mohali facility, which belonged to Ranbaxy Laboratories Ltd, has been under an import alert sounded by the US Food and Drug Administration (FDA) in 2013, two years before Sun Pharma completed its $4 billion acquisition of Ranbaxy.
Ranbaxy’s units at Dewas (Madhya Pradesh), Paonta Sahib (Himachal Pradesh) and Toansa (Punjab) are also under the FDA import alert, which bars drugs manufactured in these plants from being sold in the US market.
Sun Pharma is struggling to resolve compliance issues at Ranbaxy’s plants as well as its own manufacturing facilities at Halol and Karkhadi in Gujarat. Regulatory issues, particularly at the Halol unit, have dented the company’s sales in the US. In 2015-16, US sales were $2.07 billion, down 8% from the previous year.
1. One of the observations on the laboratory system on the company’s alleged failure to thoroughly review the reasons for an out-of-specifications batch of drugs was critical in nature, but the other observations were not as severe.
2. Another observations in the laboratory system were lack of appropriate controls over computer systems, incomplete record data, and lack of examination and testing of samples to assure that in-process materials conform to specifications.
3. The FDA observed that the quality control unit lacked the authority to review production records and to reject all procedures that have an impact on the quality of products.
4. On the production system, the company failed to present written procedures for production and process controls designed to assure that the drugs have the identity, strength, quality and purity they claim.