The US Food and Drug Administration (US FDA) has released a detailed report on six observations it reported following a recent inspection at Sun Pharmaceutical Industries plant in Dadra.
The US drug regulator had classified the plant as Official Action Indicated (OAI) after the inspection that took place between December 4 to 15 last year. “We will work with the regulator to achieve fully compliant status,” Sun Pharma had informed exchanges on the matter on April 11.
An Official Action Indicated (OAI) is the most stringent regulatory designation, as defined by the US FDA. It signifies that regulatory and/or administrative measures are likely to be recommended for the facility. This classification indicates that the regulatory body has issued observations to the plant and found the company's response to be unsatisfactory or insufficient. Facilities marked with OAIs typically undergo re-inspection by USFDA officials to ensure compliance before being cleared of any regulatory concerns.
Specific observations in the Dadra plant include the following:
1. Out of Specification (OOS) investigations are not thoroughly carried out to determine the root cause(s) for long-term stability samples failures for the drug products sold into the US market.
2. Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
3. There is a lack of Quality Unit oversight on the issuance, handling, retrieval and reconciliation of GMP (Good Manufacturing Practices) documents that are used in the manufacturing of drug products at the site.
4. Procedures describing the handling of written and oral complaints related to diug products are deficiently written or followed.
5. The firm failed to submit a Field Alert for Product Quality Complaints
6. Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration.
The recent OAI classification for Sun Pharma's Dadra unit comes on the heels of regulatory challenges faced by its Halol and Mohali facilities, leading to a downturn in the company's generic sales.
Dadra's specialisation lies in the production of oral solid dosage forms and the manufacture of the blockbuster drug Revlimid, a vital revenue driver for Sun Pharma's generics segment. Taking into account Revlimid's substantial contribution of $170 million, Nomura projects Dadra's annual sales to the US market to hover around $240 million in FY24.
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