Mumbai: US FDA found breaches of manufacturing standards at Sun Pharma’s Mohali plant during the 7-16 November visit.
The US drug regulator has found seven breaches of manufacturing standards at Sun Pharmaceutical Industries Ltd’s formulations plant in Mohali, Punjab, following a recent inspection.
The US drug regulator inspected the Mohali plant between 7 November and 16 November and issued the so-called Form 483, citing four deviations from norms in the laboratory system, two in the quality system and one in the production system, according to a copy of the Form 483 accessed by Mint.
A Form 483 is issued to a company’s management at the conclusion of an inspection when investigators observe any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic Act and related Acts.
Sun Pharma did not comment on the issue. The observations, addressed to Jila Breeze, Senior VP and head of global quality and compliance at Sun Pharma raised issues with the review process for the failure of a batch or any of its components in meeting specifications. In another observation, the FDA noted that laboratory records did not include complete data derived from all tests, examination and assay necessary to assure compliance with established specifications and standards.
Analysts said that 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.
The other observations the US FDA officials represented by a team of three investigators, Steven Kehoe, Felix Maldonaldo and Daniel Roberts, said in the report that appropriate controls were not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
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.
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.
“The first observation in the laboratory system is a little out of line, but most of the issues are fixable. However, getting the plant back to compliance will be a lengthy process for the company,” said an analyst, who did not wish to be named.
Another analyst said issues at the Mohali unit are unlikely to get resolved in the near to medium term, but there will not be any financial impact on the company as it does not supply any products to the US market from that facility.