The FDA issued drugmaker Milan Laboratories (India) a Form 483 over quality and sanitation problems observed during an August inspection of the firm’s Navi Mumbai facility.
The investigator found that procedures were not in place to validate manufacturing processes that could cause variability in products. The hold-time studies for certain tablets were not performed as required, and the dispensing quarantine hold-time study was not evaluated.
The firm’s test methods for analyzing the stability of samples were found to be inadequate. Forced degradation studies were not performed under a variety of conditions to determine their stability.