Nonconformances, Validation Cited in Warning to Gibson

Failure to investigate nonconforming products and to validate sterilization and cleaning processes resulted in a warning letter for Gibson Laboratories. The letter, posted recently to the FDA website, cited a number of violations at the Lexington, Ky., facility that makes in vitro diagnostics and agars. Gibson, a subsidiary of MicroBioLogics, rejected 14 lots of product last year due to contamination, the letter says. Its corrective action was not effective, the FDA says, noting that the company received 23 complaints about contaminated product this year and rejected another 13 lots.
The GMP Letter