Hudson Scientific Falls Short on Process Controls
An FDA inspection of Hudson Scientific’s Hudson, Mich., facility has revealed lax process control procedures and documentation.
FDA investigators found that nonconforming products were not properly documented during final acceptance activities. They observed numerous examples of failed units for which no nonconformance reports were generated by the contract manufacturing facility.
In addition, the facility lacked adequate procedures for monitoring environmental conditions and acceptance criteria for the level of humidity, according to the Form 483 inspection report.