Genzyme Smacked With 16-Observation Form 483 Over Lapses in Quality Controls
Genzyme received a 16-observation Form 483 from the FDA for not conducting risk assessments and other quality lapses at a facility where bulk drug substances are made.
During the Feb. 18 to March 18 inspection, investigators noted that the quality unit didn’t do risk assessments to detect issues that could lead to contamination during production. The unit also didn’t evaluate potential sources of contamination to determine root causes or initiate corrective actions.
Further, there was no microbial monitoring of sterile operations and the facility’s laminar flow hoods, and biosafety cabinets were in areas not classified as clean rooms.
Genzyme also failed to verify all of its testing methods, and some laboratory records lacked a second signature showing that the original records had been reviewed for accuracy, the Form 483 says. Lab records also failed to state how the results compared with established quality standards.
The investigator also dinged Genzyme’s employee training program, saying it didn’t ensure that lab workers have the experience needed to do their assigned jobs. The 483 notes that, in one case, an invalid test per Genzyme’s standard operating procedure was deemed acceptable because the trainer watched the trainee correctly follow SOP requirements when performing the test.
Finally, Genzyme had no documentation showing that access to the fermentation area was verified for specific personnel and that the access level was appropriate. And the firm’s SOP didn’t describe how to verify access, how the review would be performed or who would conduct the review.
The Lynnwood, Wash., facility produces components for Genzyme’s acute myeloid leukemia drug Leukine (sargramostim).
Company spokeswoman Erin Pascal said Genzyme is working with the FDA to resolve the issues. Read the Form 483 at www.fdanews.com/08-5-15-Genzyme483.pdf. — Kellen Owings