Manufacturer Natco Pharma was hit with a warning letter earlier this month over violations at its facility in the Indian state of Telangana, following an insufficient response to an FDA Form 483 last fall.
Until the drugmaker shows how it fixed the issues in the warning letter, Natco has suspended making products at the facility for the US, the agency said.
Among the violations that were laid out in the April 8 letter, the FDA said the facility failed to adequately clean, sanitize or sterilize equipment at the rate that would prevent contamination or malfunction. It also said Natco didn’t adequately investigate unexplained discrepancies in batches of product, including missing records.
In a statement on its website dated April 9, Natco said the warning shouldn’t impact existing supply from the facility, but that there might be delays or withholding of pending product approvals from the site. Natco said it would work closely with the FDA to address the issues.
Endpoints News reached out to Natco for comment on Tuesday and didn’t immediately receive a response.
Natco was given 15 days from the date it received the letter to respond. The FDA is asking the company to provide a comprehensive assessment of its cleaning procedures and what led to the violations in the first place. It also asked Natco for its plan for how and when it will resolve the issues. The warning letter also directs Natco to conduct a comprehensive assessment of its record-keeping practices and come up with a plan to remedy the issues.
Headquartered in Hyderabad with eight locations throughout India, Natco manufactures active pharmaceutical ingredients and finished dosage formulations.