Eli Lilly has received an FDA warning letter for quality issues in the manufacturing of Humalog at its Carolina, Puerto Rico facility. Based upon inspections last year, FDA cited the facility for faulty API test methods:
You released 24 of the 36 API batches based on the test results despite your failing to validate the test method and your knowledge of a similar (b)(4) event at one of your sister plants (as indicated during the inspection). This event resulted in that facility's rejection of the material and the extensive cleaning of the (b)(4) unit.
The Agency also noted that Lilly did not specify how the manufacturer would resolve the issues at the facility:
We acknowledge your response dated August 21, 2009, where you commit to: 1) stop using the (b)(4) as an additional criteria to recommend forward processing; 2) enhance cleaning activities to prevent (b)(4) and 3) enhance the visual appearance inspection to readily detect the presence of (b)(4) material (if (b)(4) occurs). However, your response does not address the specific changes that you have made to your cleaning procedures and visual appearance inspection, or whether upstream detection of (b)(4) will be possible using current process controls.
For the entire letter, click here.