FDA 483 - Symbiotec Pharmalab Limited - May 05, 2017

An FDA inspection conducted from May 1 to May 5, 2017, at Symbiotec Pharmalab Private Limited in Pithampur, India, revealed significant deficiencies in their manufacturing and quality control processes. The inspection, documented in a Form FDA 483, highlighted a range of issues indicating non-compliance with Good Manufacturing Practices (GMP) for API manufacturers. Key violations included a widespread lack of data integrity, with essential records such as quality control issuance logs and raw material protocols reported as missing. Furthermore, discrepancies were found between employee activity records and biometric system data, suggesting personnel were documented as performing critical GMP-related tasks, including training, temperature monitoring, and tank cleaning, when they were not physically present on site. The firm was also cited for using an unvalidated test method for the chromatographic purity of an API intermediate, leading to product failure during stability testing. Other issues involved the absence of a comprehensive risk assessment for computer system validation to ensure 21 CFR Part 11 compliance, failure to conduct required supplier requalification audits, and the use of an unqualified test device for evaluating primary packaging materials. Symbiotec Pharmalab is required to respond to these observations by outlining corrective and preventive actions to ensure compliance with regulatory standards and address the identified systemic issues.