British Devicemaker Is Cited for Nonconforming Devices

Alba Bioscience retested and released several lots of nonconforming devices without a quality assurance investigation or approval, according to an FDA warning letter.

The FDA cited the British company, which manufactures blood grouping reagents, for releasing several lots that failed to meet its licensed final release specifications.

Alba also did not have procedures for corrective and preventive action and failed to conduct an investigation after finding nonconformities in its products, processes and quality system, according to the warning letter.
The GMP Letter