Cipla Pithampur unit gets FDA Warning letter Read More..

Cipla in a statement informed that its Pithampur, Indore facility is issued an USFDA Warning letter on 17 Nov 2023. The site was inspected in Feb 2023 by USFDA investigators Saleem A Akhtar, Jose E Melendez. Qvents had posted  in April 2023 about deficient Complaint handling cited in the FDA 483 issued to Cipla following the February 2023 inspection.

Other observations in the Cipla Pithampur USFDA 483 include:

• Deficient procedures to prevent microbial contamination of sterile products (media fill studies do not address power breakdowns, all cleaning interventions)
• Deficient aseptic processing area with turbulent airflow
• Deficient control over computers in manufacturing area and the electronic data; the electronic data are overwritten and not available for review.
• Failure to file FAR (Field Alert Reports) within stipulated time for complaints received
• Failure to retain GMP records; GMP documents, torn pieces of printer weigh slips observed in scrap
• Failure to take market action after failure in stability (Non-US Batches)
• Non-contemporaneous recording of entries in LIMS, failure of QA to review microbial counts on media plates
• Control over photographs of media plates taken after counting colony forming units (CFUs) are deficient; can be deleted. Electronic records of time and date of photographs can be changed.

In the statement, Cipla informed that it will respond to the Warning Letter within the stipulated timelines and work closely with the USFDA to address the concerns in a holistic and timely manner.

USFDA 483