Strides Pharma Plant: “Significant Violation,” Claims FDA


The United States Food and Drug Administration (FDA) found “significant violations” at the Strides Pharma Sciences plant. The FDA is questioning the pharma company’s quality control practices after it was found that the plant had “uncontrolled shredding of documents” at one of their plants.

The Puducherry plant in southern India violated several current good manufacturing practice (CGMP) regulations.

Shares of the company plummeted 8% on the news to reach a new one-year low.

Strides acknowledged receiving a warning letter on July 2 in the company’s securities disclosure stating that the warning will not impact the company’s manufacturing of six drugs approved by the FDA. The company claimed that the 10 new drug applications that are awaiting approval from the FDA will have to be deferred while the plant is reclassified.

Investigators found that the company shredded several documents, including bags of CGMP documents which relate to the laboratory operations, drug production and quality at the plant. A batch of records found in a binder were found in a barrel outdoors.

The FDA also found a 55-gallon drum in the company’s scrapyard which contained CGMP records. Some of the documents that had been discarded were from one week prior to the inspections.

The company also failed to adequately investigate OOS test results. FDA officials found that the company abruptly closed the investigation of one of their APIs without “adequate scientific justification.” The original failing sample was never investigated, and the company used a passing sample with new ingredients for the release of the API.

FDA officials are demanding that the company correct the violations and provide an assessment to the extent of the data integrity deficiencies at the plant. The company must also provide a full assessment on the potential effects of the deficiencies and what they mean to the quality of the drug.