Private Sector Florida Whistleblower Act Amended Complaint.
Plaintiff Ramirez. Plaintiff Ramirez.
Case 8:10-cv-02003-RAL-TGW Document 7-1 Filed 11/02/10 Page 8 of 25 PageID 160 process to report non-conforming conditions, to the Quality Team Leader ANITA MUJAGIC and Manufacturing Manager KENNETH PATTERN regarding the contamination/adulteration, and the operator refusal to stop the line. Later Plaintiff met with THOMAS, the Quality Group Leader, and the Manufacturing Filling Operator to emphasize his concerns about the contamination/adulteration of the product. Additionally, Plaintiff forwarded a report about his concerns to MUJAGIC on March 14, 2008. 26. On March 18, 2008, Plaintiff observed anomalies while performing required Quality Control activities on Line 10 for the manufacture of B&L’s Soothe®XP Emollient (Lubricant), which are eye drops containing a lipid restorative Restoryl. Plaintiff asked the manufacturing operator to stop the line when he observed units with apparent contaminants located at the dispensing tube tips. He notified the “set up” mechanical technician of need for a machine adjustment on the production line. In the meantime, Plaintiff observed manufacturing defects on production Line A, again requiring an unplanned stopping of the production there. Upon moving to start a protocol run on Line 1, Plaintiff observed the production line operating without an attending operator to monitor the medication filling machine operations. He objected and requested the “set up” mechanical technician to stop the line. When Plaintiff returned again to the Line 10 production line to recheck its status, Plaintiff discovered that the Quality Group Leader had closed Plaintiff’s non-conformity comment in the batch folder record and assigned another Quality Control associate to replace Plaintiff. 27. On March 19, 2008, Plaintiff reported nine units on the medication filling line with foreign particulates at the dispensing tips in violation of the prescribed accept/reject criteria for quality control. After corrective mechanical adjustments to the line were attempted, Plaintiff still found thirty medication units after each adjustment to be defective. Thereupon, the Quality First Amended Complaint, page 8
Case 8:10-cv-02003-RAL-TGW Document 7-1 Filed 11/02/10 Page 9 of 25 PageID 161 Group Leader ordered the Plaintiff to record only two defective units in the batch folder, an inaccurate production anomaly number low enough to allow manufacturing to continue within the SOPs. The Quality Group Leader also assigned an alternate Quality Control associate to enter the understated anomaly reports on the incident into the official records. 28. On March 25, 2008, Plaintiff was working the manufacturing fill line #4 for product albuterol sulfate, a drug inducing bronchial smooth muscle relaxation to aid breathing. The manufacturing operators completed a production run of three hundred units without compliance with bottle container testing and quality control procedures. Upon inspection, the Plaintiff discovered broken glass on the production line. Plaintiff stopped the line and segregated all units based on the control set point of the preceding quality control check. When the Plaintiff attempted to remove these 300 units per the SOPs, he was ordered not to do so. Chemistry/Environmental Associate WANDA ROSARIO subsequently informed the Plaintiff that she witnessed broken glass containers being processed on Filling Line #4, but that the line operators failed to follow the required SOPs for prescribed remedial action. The anomaly was not recorded in the batch folder records as required by SOPs by those responsible for said records. 29. On March 27, 2008, Plaintiff attended a meeting with Quality Team Leader MUJAGIC and THOMAS in which he attempted to address his quality and safety concerns described above, as well as the negative responses and hostile reactions he received and was still receiving as a result of expressing those concerns to production technicians and supervisors. 30. On April 4, 2008, Plaintiff met with Manufacturing Manager PATTERN to discuss and seek resolution to his quality and safety concerns described above. First Amended Complaint, page 9
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Case 8:10-cv-02003-RAL-TGW Document 7-1 Filed 11/02/10 Page 8 of 25 PageID 160<br />
process to report non-conforming conditions, to the Quality Team Leader ANITA MUJAGIC<br />
and Manufacturing Manager KENNETH PATTERN regarding the contamination/adulteration,<br />
and the operator refusal to stop the line. Later Plaintiff met with THOMAS, the Quality Group<br />
Leader, and the Manufacturing Filling Operator to emphasize his concerns about the<br />
contamination/adulteration of the product. Additionally, Plaintiff forwarded a report about his<br />
concerns to MUJAGIC on March 14, 2008.<br />
26. On March 18, 2008, Plaintiff observed anomalies while performing required<br />
Quality Control activities on Line 10 for the manufacture of B&L’s Soothe®XP Emollient<br />
(Lubricant), which are eye drops containing a lipid restorative Restoryl. Plaintiff asked the<br />
manufacturing operator to stop the line when he observed units with apparent contaminants<br />
located at the dispensing tube tips. He notified the “set up” mechanical technician of need for a<br />
machine adjustment on the production line. In the meantime, Plaintiff observed manufacturing<br />
defects on production Line A, again requiring an unplanned stopping of the production there.<br />
Upon moving to start a protocol run on Line 1, Plaintiff observed the production line operating<br />
without an attending operator to monitor the medication filling machine operations. He objected<br />
and requested the “set up” mechanical technician to stop the line. When Plaintiff returned again<br />
to the Line 10 production line to recheck its status, Plaintiff discovered that the Quality Group<br />
Leader had closed Plaintiff’s non-conformity comment in the batch folder record and assigned<br />
another Quality Control associate to replace Plaintiff.<br />
27. On March 19, 2008, Plaintiff reported nine units on the medication filling line<br />
with foreign particulates at the dispensing tips in violation of the prescribed accept/reject criteria<br />
for quality control. After corrective mechanical adjustments to the line were attempted, Plaintiff<br />
still found thirty medication units after each adjustment to be defective. Thereupon, the Quality<br />
First <strong>Amended</strong> <strong>Complaint</strong>, page 8
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