FDA 483 - Symbiotec Pharmalab Limited - May 05, 2017

Symbiotec Pharmalab Private Limited in Pithampur, India, received a Form 483 with six observations following an inspection. The inspection revealed significant issues including missing critical records, discrepancies between documented GMP work and employee presence, and the use of an invalid test method in an API stability program. Additionally, the firm failed to conduct a full risk assessment for computer system validation, did not perform required supplier requalifications, and used an unqualified test device for packaging material release.