Eagle Analytical Services — FDA 483 Findings

Laboratory controls do not include c.he establishment of scientifically sound and appropriate specifications, standards, and test pr010edures designed to assure that components conform to appropriate standards of identity, strength, quality and purity.

There is no quality control unit.

Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.

Written records are not made of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications.

Deviations from written specifications arc not justified.

GMP training is not conducted on a continuing basis to assure that employees remain familiar with CG~ requirements applicable to them.

Laboratory records do not include the initials or signarure of a second person showing that the original records have been reviewed for accuracy, completeness, and compliance with established standards.