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 4 of 25 PageID 156 conjunctivitis, dry eye, glaucoma, and retinal diseases, nutritional supplements, and ophthalmic refractive and cataract surgical equipment and products. 13. Defendant hired Plaintiff in February 2006. Plaintiff began his training on March 6, 2006. Plaintiff was employed by B&L until his termination on November 11, 2008. 14. In or about February 2006, as part of the screening process for hire, Plaintiff was subjected to a physical, including an examination of vision. At that time, Defendant learned Plaintiff had medical condition affecting his left eye commonly known as amblyopia, a monocular vision impairment (“lazy eye”), an impairment that may be determined to constitute a disability under state or federal law. 15. The U.S. Food and Drug Administration (“FDA”) enforces current Good Manufacturing Practices (cGMPs) and regulations consistent with its authority under the Federal Food, Drug, and Cosmetic Act of 1938, 21 U.S.C. § 351, as amended by the 1976 Medical Device Amendments. On November 9, 2005, Congress amended the Food, Drug and Cosmetic Act to classify all contact lenses and contact lens care products as medical devices under FDA’s regulatory authority. 16. Plaintiff was required to perform a number of tasks in his job, including review of processing records to insure conformance to current Good Manufacturing Practice (cGMPs) and Standard Operating Procedures (SOPs), the release of production lines to manufacturing, the verification of products and components, the conduct of on-line inspections, the continuous monitoring of processes, the identification and report of non-conformances, the performance of investigations and development of corrective actions, and certifications. 17. Current Good Manufacturing Practices (cGMPs) are regulatory requirements for all manufacturers of drugs and medical devices, codified at 21 C.F.R., Parts 210, 211, 600 and First Amended Complaint, page 4
Case 8:10-cv-02003-RAL-TGW Document 7-1 Filed 11/02/10 Page 5 of 25 PageID 157 820. GMP regulations prescribe that a regulated entity must implement a set of standard operating procedures to ensure that drugs and medical devices are manufactured to be safe and effective through employee training, quality design, manufacture, labeling, testing, storage, and distribution. The requirements in these regulations and 21 C.F.R. Part 820 (hereafter “the CFRs”) govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use. Defendant is required to conduct its business in compliance with various federal and state laws, rules, and regulations governing medical devices and drugs, including these cGMP regulations. 18. The Standard Operating Procedures (SOPs) to which the Plaintiff was to ensure compliance constitute procedures mandated by the FDA and the CFRs to be in place and enforced by the Defendant. The Defendant promulgated specific SOPs designed to insure compliance with federal regulations, including, but not limited to: (1) SOP 60-021 “Cleaning and Sanitization of the Aseptic Core” setting forth specific comprehensive required procedures for cleaning the aseptic core; (2) SOP 61-064 “Proper Attire Within the Manufacturing Facility” mandating gowning, uniforms, and personal cleanliness to ensure clean and controlled manufacturing; (3) SOP 62-034 “Packing and Inspecting Filled Product Into Intermediate Trays” setting forth requirements for inspection, for stopping the line and documenting findings when inspection reveals internal foreign material or external cracks or physical defects. SOP 62-034 requires that caps not be missing, loose, crooked, or dented. SOP 62-034 mandates stopping the filling process, documenting findings in the batch record, and placing a QA Hold per Policy PP 04, if any "internal foreign material" is found during the inspection process. The SOP defines internal foreign material as any particle or substance, including glass; which can be seen inside the bottle or in the solution during the visual inspection process. First Amended Complaint, page 5
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Case 8:10-cv-02003-RAL-TGW Document 7-1 Filed 11/02/10 Page 5 of 25 PageID 157<br />
820. GMP regulations prescribe that a regulated entity must implement a set of standard<br />
operating procedures to ensure that drugs and medical devices are manufactured to be safe and<br />
effective through employee training, quality design, manufacture, labeling, testing, storage, and<br />
distribution. The requirements in these regulations and 21 C.F.R. Part 820 (hereafter “the<br />
CFRs”) govern the methods used in, and the facilities and controls used for, the design,<br />
manufacture, packaging, labeling, storage, installation, and servicing of all finished devices<br />
intended for human use. Defendant is required to conduct its business in compliance with<br />
various federal and state laws, rules, and regulations governing medical devices and drugs,<br />
including these cGMP regulations.<br />
18. The Standard Operating Procedures (SOPs) to which the Plaintiff was to ensure<br />
compliance constitute procedures mandated by the FDA and the CFRs to be in place and<br />
enforced by the Defendant. The Defendant promulgated specific SOPs designed to insure<br />
compliance with federal regulations, including, but not limited to:<br />
(1) SOP 60-021 “Cleaning and Sanitization of the Aseptic Core” setting<br />
forth specific comprehensive required procedures for cleaning the<br />
aseptic core;<br />
(2) SOP 61-064 “Proper Attire Within the Manufacturing Facility”<br />
mandating gowning, uniforms, and personal cleanliness to ensure<br />
clean and controlled manufacturing;<br />
(3) SOP 62-034 “Packing and Inspecting Filled Product Into Intermediate<br />
Trays” setting forth requirements for inspection, for stopping the line<br />
and documenting findings when inspection reveals internal foreign<br />
material or external cracks or physical defects. SOP 62-034 requires<br />
that caps not be missing, loose, crooked, or dented. SOP 62-034<br />
mandates stopping the filling process, documenting findings in the<br />
batch record, and placing a QA Hold per Policy PP 04, if any "internal<br />
foreign material" is found during the inspection process. The SOP<br />
defines internal foreign material as any particle or substance, including<br />
glass; which can be seen inside the bottle or in the solution during the<br />
visual inspection process.<br />
First <strong>Amended</strong> <strong>Complaint</strong>, page 5
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