Divi's Laboratories Ltd. (Unit II) – FDA 483, Dec 6, 2016

This FDA Form 483 details significant quality system and manufacturing deficiencies. The facility, which produces APIs, intermediates, and development products, failed to exercise proper control over computerized analytical systems, leading to unscientific disregard of unknown impurities and inaccurate reporting.

Observations included unexplained colored product and residue on API manufacturing equipment, inconsistent with product coloration, and commingled with product, raising cross-contamination concerns. Particulates were found on inner equipment surfaces, and divets/chipping were observed in manufacturing equipment. The firm's preventative maintenance checks did not address equipment integrity.

Critical findings involved product failing specifications, with R&D instructing onward processing or alternative analysis, incorporating failing material. Multiple Inter Office Memorandums (IOMs) documented instances where out-of-specification (OOS) results were re-analyzed until specifications were met, or batches were processed despite deviations, often without identifying root causes. One OOS batch was confirmed but released.

The firm failed to conduct thorough investigations. Complaints regarding foreign material and heavy metals in products were received, but investigations did not identify a definite root cause, nor did they suggest product recall or comprehensive assessment for these contaminants across products. The firm also acknowledged difficulty removing certain deposits, with no suitable alternative cleaning procedures identified.