FDA 483 - Dasami Lab Private Limited - June 01, 2018

An FDA inspection conducted at Dasami Lab Private Limited, an API manufacturer in Nalgonda District, Telangana, between May 28 and June 1, 2018, resulted in the issuance of an FDA Form 483 outlining several significant observations. The firm was found to lack stability data necessary to support the retest date for a manufactured drug substance. Inspectors also noted the absence of equipment log books for analytical balances in the Quality Control laboratory until the inspection date, indicating a failure to adequately document usage. Crucially, the company demonstrated inadequate analytical method transfers and verifications. This included a lack of proper transfers for analytical test methods used to assess starting materials and insufficient verification of methods for the drug substance prior to testing process validation and commercial batches. Additionally, the firm's procedure for handling power failures was deemed deficient, failing to define "critical operations" and lacking documentation and assessment of equipment stoppages during outages on batch production records. Dasami Lab Private Limited is expected to respond to these observations with detailed corrective actions to ensure compliance with regulatory standards.