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 6 of 25 PageID 158 (4) SOP 71-103, “Product Sampling” establishing a uniform procedure for determining what constitutes an appropriate sample size; and (5) SOP 71-017 “Visual Inspection” describing in extensive detail the procedure for the Quality Coordinator’s visual inspection of ointments, creams, gels, solutions, and suspensions, and rejection of products and documentation of inspection results. SOP 70-017 requires packaging tips to be correct in color, uniform in appearance, and free of particles, shavings, product or foreign residue. SOP 70-017 requires that glass units must be free of cracks. 19. Defendant’s Policy PP-04, which is mandated by the federal regulations set forth below, states that all potential non-conformances must be documented on a Material Evaluation Report (MER) and accompanied by an investigation and samples of any defects, including adulteration or contamination. “Contamination”, under FDA rules, includes a non-conforming condition caused by the intrusion or presence of any foreign object in the manufacturing processes, containers, packaging or product produced. “Adulteration”, under FDA rules, includes any product unit or product batch that is not manufactured, processed, marketed or transported in accordance with federal regulations or the manufacturer’s approved SOPs. 20. The MER serves as a primary and federally mandated reporting and evaluation mechanism for actual or potential manufacturing or use of non-conforming raw materials, components, in-process and/or finished products that do not meet approved manufacturing specifications. An MER investigation is necessary for assessing the impact on the contaminated, adulterated, or otherwise non-conforming or affected product and/or products or processes and for determining required corrective actions. The Material Review Board is responsible for the final disposition, dissemination, filing and retention of MERs. 21. Plaintiff has always performed his job in a competent manner or better. On October 31, 2007 and again on January 18, 2008, the Plaintiff received awards from Defendant for “focus on excellence.” First Amended Complaint, page 6
Case 8:10-cv-02003-RAL-TGW Document 7-1 Filed 11/02/10 Page 7 of 25 PageID 159 22. After being employed by B&L for one year, Plaintiff began applying for other positions and promotions, which in reverse chronological order were: (a) Compounder I (March 2008); (b) Production Data Associate (January 2008); (c) Administrative Assistant (November 2007); (d) Documentation Analyst (June 2007); (e) Group Leader II (May 2007); and (f) Group Leader II/Manufacturing (April 2007). Plaintiff was qualified and credentialed for the positions he sought. 23. Although Hispanics received some of the positions applied for by Plaintiff, their national origin was Puerto Rican. Upon information and belief, the Plant Manager participated in the decisions regarding the promotion. The Plant Manager is of Puerto Rican national origin and showed favoritism to Puerto Rican applicants. Plaintiff’s national origin is Chilean. VI. FACTS REGARDING PROTECTED ACTIVITY 24. On or about June 2007, Plaintiff first complained to B&L that he was being bypassed from promotion based on his national origin. 25. On March 13, 2008, Plaintiff reported that he discovered certain batches and/or units of B&L’s Muro 128® Ointment for corneal edema were contaminated with foreign particulate around the dispensing tube tip. Plaintiff stopped the production line, and the “set up” mechanical technician was instructed to make corrective adjustments to the production line. After the restart of the line, Plaintiff observed defects on the product tube tips, including fibrousappearing contaminants and tube caps adulterated by disconfiguration. Plaintiff twice requested that medication-filling operator MARILYN GUADALUPE halt the line. GUADALUPE ignored his requests, resulting in uncontaminated and/or unadulterated “good” units being comingled with apparently contaminated and/or adulterated units. Plaintiff informed his Manufacturing Team Leader PAMERLY THOMAS that he would submit email notifications, an allowed First Amended Complaint, page 7
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Private Sector Florida Whistleblower Act Amended Complaint.

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