Private Sector Florida Whistleblower Act Amended Complaint.

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Case 8:10-cv-02003-RAL-TGW Document 7-1 Filed 11/02/10 Page 10 of 25 PageID 162 31. On May 13, 2008, the Plaintiff discovered seven non-conforming units warranting rejections while assisting a colleague with her hourly quality control inspection duties. When said colleague reported this to Quality Group Leader GORDON, he instructed her to ignore the non-conformities and enter no reported findings to the contrary. 32. On May 14, 2008, the Plaintiff observed that a line operator failed to change her prescribed personal protective clothing though it was considered contaminated after contact with the production floor, in violation of SOP 60-029-24. Plaintiff reported this nonconformity to the Training Certification Specialist JO GALLO, who agreed that there was a violation and suggested that the Plaintiff himself educate the operator to proper application of said SOP. This ad hoc supervisory and training protocol also violated the SOPs and CFRs governing training and supervision. 33. On May 20, 2008, the Plaintiff informed THOMAS and Manufacturing Group Leader ANDRE BENT that he had detected a non-conforming manufacturing process due the presence of an unidentified bottle container with improperly labeled product. An MER and disciplinary action resulted as to the offending associates for violation of SOPs. 34. On May 21, 2008, the Plaintiff reported to Defendant’s Chemistry Management staff DOUG COMMERCE and JUDITH RODRIGUEZ that Associate MADELINE GUADALUPE had failed to log into an operating production. Accurate personnel logging is critical to required trace-back procedures in the event of subsequently discovered contamination/adulteration. The Plaintiff also reported 53,300 units of Fluress (Fluorescein and Benoxinate) anesthetic agent solution being contaminated/adulterated due to the presence of glass fragments in the packaging stage. The Plaintiff complained that this contamination/adulteration incident shared the same root cause and the same associates as prior First Amended Complaint, page 10
Case 8:10-cv-02003-RAL-TGW Document 7-1 Filed 11/02/10 Page 11 of 25 PageID 163 events, meriting investigation and corrective action under SOPs. The Plaintiff complained that the required documentation per the SOP was missing or improperly recorded. 35. On May 21, 2008, following up on discussions the Plaintiff had with WANDA ROSARIO about the recurring breakages on production line 4, the Plaintiff requested that ROSARIO identify the SOPs governing the cleaning steps an operator must follow to remediate glass contamination/adulteration. 36. On May 30, 2008, the Plaintiff expressed concern to Quality Group Leader GORDON that he had not received the SOP prescribed level of training sufficient to enable him to enter training form certifications in the Defendant’s data system. 37. In or about June 2008, the Plaintiff complained about being bypassed from promotion based on his national origin after being denied the Compounder I position in May 2008. 38. On June 10, 2008, the Plaintiff notified THOMAS and GORDON that he discovered excess unit counts in the filling production line. THOMAS and GORDON told the Plaintiff to take no action other than discarding the excess unit. The Plaintiff objected because SOPs set forth a specific procedure governing responses to excess unit counts. SOP 60-021 “Cleaning and Sanitization of the Aseptic Core” also specifies that the sanitization process include a line clearance of rejected filled and empty containers at the end of each working shift. Later that day, the Plaintiff objected to THOMAS that a filling associate was present inside the manufacturing area without wearing prescribed personal protective clothing, in violation of SOP 61-064, which prescribes guidelines for “Proper Attire Within the Manufacturing Facility”. 39. On June 12, 2008, in response to the Quality Control Supervisor’s inquiries, the Plaintiff objected to her accusatorial interrogation of him as to justifications for his prior First Amended Complaint, page 11
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Private Sector Florida Whistleblower Act Amended Complaint.

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