U.S. FDA Flags Six Quality And Procedural Lapses At Sun Pharma’s Mohali Plant

The U.S. drug regulator has flagged quality control and procedural lapses at Sun Pharmaceutical Industries Ltd.’s Mohali facility.

The U.S. Food and Drug Administration inspected Sun Pharma’s drug manufacturing facility at Mohali, Punjab from Aug. 3 to Aug. 12, the company had said in an Aug. 13 exchange filing. “At the conclusion of the inspection, the U.S. FDA issued a Form 483 with six observations,” it said without disclosing any details.

The company, the filing said, is preparing the response to the observations, which will be submitted to U.S. FDA within the stipulated timeline.

A Form 483 is issued when investigators have observed any condition that in their judgment may constitute violation of the Food Drug and Cosmetic Act and related acts.

BQ Prime has obtained a copy of the observations from the FDA.

These are:

1. The company failed to thoroughly review unexplained discrepancies.

• It did not adequately review confirmed instances of backdating of GMP (good manufacturing practices) records. The QA (quality assurance) reviewers were asked not to document observations in order to avoid lab events or deviations, to ensure timely release of products, the quality audit did not include specific actions that would further identify whether backdating was still occurring or the extent of previous backdating and additional employees were not interviewed to evaluate scope of backdating.

• Investigation into backdating of QC (quality control) laboratory report was closed stating “not enough information to initiate an investigation”.

• Out of specification investigation had confirmed cross-contamination in products which led to recall of batch. Some batches, however, were released to the market because the detected cross-contamination was below the specification for unknown impurities. The investigation could not determine if cross contamination was uniformly distributed throughout the batch.

2. Established sampling plans, test procedures and laboratory control mechanisms are not documented at the time of performance.

• Building access records showed an employee responsible for collecting samples did not enter the buildings where the samples were documented to have been collected or that the employee was in a different building at the time the sample was documented to have been collected.

• Entries were not made into GMP records contemporaneously.

3. Written procedures are not drafted, reviewed and approved by the appropriate organizational units and reviewed and approved by the quality control unit. In-process controls quality attributes was not evaluated and certain review data was not considered during the recommendation for corrective actions.

4. Laboratory records are deficient as they do not include a complete record of all data obtained during testing. Original records were not documented to justify change in processing of chromatography data.

5. Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures to assure the quality and purity of drug products. Three instances where procedures were required to be established were highlighted.

6. Written procedures are not followed for the testing of components. The company did not properly follow the reduced testing procedure and it also failed to reevaluate it under its other written procedure.

India’s largest drugmaker has yet to respond to BQ Prime’s emailed queries on the implications of the observations, the revenue contribution of the facility, and impact on future approvals and launches.

The company is also yet to comment on the steps been taken to address these issues and the expected timelines.

Vishal Manchanda, pharma analyst with Systematix, told BQ Prime that the “first two observations seem serious”.

The U.S. contributed 30% to Sun Pharma’s total sales in the quarter ended June 2022.

Shares of Sun Pharma fell as much as 1.7% intraday on Friday, and are on course to extend the losing streak for the second day. Since Aug. 12, the stock has lost 1.5%.

Of the 44 analysts tracking the company, 40 maintain a ‘buy’, three suggest a ‘hold’ and one recommends a ‘sell’, according to Bloomberg data. The 12-month target price implies an upside of 17%.