With the FDA getting ready to knock on their door, officials at Strides Pharma Science Ltd. appear to have attempted to destroy quality-control documents.
The discovery was made at the company’s Puducherry plant in Southern India. According to a warning letter from the agency, FDA inspectors found shredded records in a 55-gallon drum in the company’s scrap yard. Among the documents were CGMP records that included batch records dated seven days before the inspection that had not been reviewed by the company’s quality unit.
The FDA said that the apparent destruction of documents along with a lack of adequate data integrity has raised questions about the safety and efficacy of drugs produced at the plant. Strides makes several products for export to the U.S., including ibuprofen.
The warning comes as several companies in India face increased quality-control scrutiny brought on by a widespread recall of blood pressure medications, many of which were manufactured in India and China.
Read the full Reuters report.
