The QMN Weekly Bulletin

Qiagen Earns Warning Letter Over TB Test Failures

July 8, 2016

The FDA issued a scathing warning letter to Germany-based Qiagen for numerous quality system failures related to its QuantiFeron TB test.

During an inspection at the firm’s Hilden, Germany plant Feb. 26 to April 8, inspectors noted that multiple CAPAs were opened due to repeated complaints for high false positive readings for the TB test.

The firm implemented corrective actions but they weren’t effective because the contract manufacturer wasn’t able to meet the new specifications, and there was no endotoxin specification change, the May 16 warning letter notes.

Another CAPA was opened due to endotoxin contamination found in two lots of blood collection tubes, which could lead to false-positive results.

The agency chided the firm for not establishing adequate controls for suppliers and contractors, noting that the firm’s contract manufacturer did not have adequate process validation procedures in place.

But the firm’s response was inadequate because it did not address any updated quality requirements with the contract manufacturer to ensure that appropriate endotoxin levels could be met.

Inspectors also found fault with the firm’s design change procedures in that design output for the TB test was changed but a design change was not opened and the specification was not verified. In addition, there was no verification for the Nil blood collection tube.

The warning letter slammed the company for not adequately investigating complaints. It notes that despite numerous complaints over the false-positive tests, tube lot information was obtained for only 12 of the complaints.

Qiagen also failed to submit medical device reports to the FDA within 30 days as required by 21 CFR 803.50. The agency also dinged the firm for failing to submit a written report to the FDA of a correction or removal of a device.

Keep pace with the latest worldwide inspections news by subscribing to FDAnews’ Inspection Insider. Nowhere else will you find a more comprehensive collection of inspections intelligence. With Inspection Insider, you’ll have an unmatched source of critical information to ensure you’re prepared when investigators come knocking.