Private Sector Florida Whistleblower Act Amended Complaint.

Case 8:10-cv-02003-RAL-TGW Document 7-1 Filed 11/02/10 Page 22 of 25 PageID 174
The responsibilities and procedures applicable to the unit must be followed and in
writing.
7. Microbial control (drugs): 21 C.F.R. 211.113 requires the Defendant have appropriate
written procedures to prevent contamination and adulteration.
8. Testing (drugs): 21 C.F.R. 211.165 requires the Defendant to create and follow
adequate sampling and testing plans to ensure drug quality and to reject drugs failing to
meet standards or specifications.
9. Documentation (drugs): 21 C.F.R. 211.188 requires the Defendant to maintain batch
production and control records with complete information about the drug production,
including the personnel involved in the process, and the results of any investigation into
product discrepancies.
10. Production Record Review (drugs): 21 C.F.R. 211.192 requires that the Defendant
have the quality control unit review and approve all drug product production and control
records to ensure compliance with SOPs and to thoroughly investigate and record any
discrepancies or failures to meet specifications.
11. Investigations Required (drugs): 21 C.F.R. § 211.198 requires the Defendant to
follow written procedures to handle all complaints about a drug product, including how
and whether to conduct a formal investigation or report to the FDA.
91. Defendant had knowledge of each of the Plaintiff’s disclosures, complaints,
reports and protected activity set forth above in the “Facts Regarding Protected Activity” section
hereof, including his reports of violations of SOPs, cGMPs, and CFR sections. Each of said
disclosures, complaints and reports demonstrate that the Defendant violated one or more of the
laws, rules and regulations enumerated in paragraphs 90.1 to 90.11.
First Amended Complaint, page 22