Sun Feb 23 06:51:03 UTC 2025: **US FDA Slaps Indian Drug Maker with Warning Letter for Manufacturing Lapses**
**New Delhi, February 23, 2025** – Jagsonpal Pharmaceuticals, an Indian pharmaceutical company, has received a warning letter from the U.S. Food and Drug Administration (USFDA) citing significant manufacturing deficiencies at its Rajasthan-based active pharmaceutical ingredients (APIs) plant.
The USFDA inspection, conducted over three days in March and April 2024, uncovered multiple deviations from Current Good Manufacturing Practice (CGMP) for APIs. The agency stated that these deviations resulted in the company’s APIs being deemed adulterated. The letter specifically points to inadequate quality systems and the failure of the company’s quality unit to ensure CGMP compliance at a contract facility. The USFDA considers contractors as extensions of the manufacturer and holds the company responsible for the quality of its drugs regardless of contractual agreements.
The warning letter also notes that inspectors were initially denied full access to the facility on March 15, 2024, further contributing to the violations. This denial, along with the identified deviations, led to the API’s being deemed adulterated.
The USFDA demands a detailed written response within 15 working days outlining corrective actions and preventative measures to address the deficiencies. The agency warns that failure to adequately address these issues could result in the withholding of approval for new applications or supplements and potential re-inspections. The agency also recommended that Jagsonpal Pharmaceuticals engage a qualified consultant to assist in achieving CGMP compliance.
First Piper 