Home » Nonconformances, Validation Cited in Warning to Gibson
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
The GMP Letter
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