FDA 483 - Cipla Limited - April 04, 2024

This FDA Form 483 details six observations from an inspection of a facility manufacturing active pharmaceutical ingredients (APIs) and drug products for the US market, including tablets USP.

**Observation 1** notes a failure to properly clean and maintain equipment. Specifically, on April 2, 2024, two flying insects were found in the bowl of a piece of equipment (bTC)405 used for I \DJ\•f USP API manufacture. On April 3, 2024, a large gap and external damage (dents) were observed in the duct of (bTC)~405, approximately 4 feet from the valve, allowing an 8x11 inch paper to be inserted, indicating a breach unknown to the firm.

**Observation 2** states that equipment and utensils are not cleaned and maintained at appropriate intervals. On March 28, 2024, unknown white residue was found on the shaft and bolt of equipment being cleaned after processing a previous batch of tablets.

**Observation 3** identifies a failure to adequately investigate out-of-specification (OOS) results. Since May 2020, eight OOS investigations related to particle size distribution (PSD) for API manufactured at Unit- (b)(4) have occurred, with one (OOS-10 2024-00013) remaining open. The firm has not hol