Opinion ID: 152316
Heading Depth: 2
Heading Rank: 1

Heading: Requests for Technical Documents

Text: Sometime prior to 2003, Bristol-Myers' Barceloneta plant was identified as a possible back-up site for the production of Atazanavir, an HIV treatment. Before the site could obtain federal approval to begin production, it had to undergo preapproval inspection by the FDA. In January 2003, Ramon Corcino, Director of Quality Assurance and Quality Control for the Barceloneta site, sent an email to Collazo and several other employees about an upcoming FDA preapproval inspection in preparation for Atazanavir production. The email stated: Team, Unless someone objects, I will advise we are ready. We did the readiness exercise last year and just have to make sure that what we did recently regarding the re-validation of the ultimate synthesis step is in order. Of course, this include[s] facilities that need to be clean and in good state of repair. Collazo was concerned that there were deficiencies in the documentation of certain laboratory procedures and results related to Atazanavir production. In response to Corcino's email, he made efforts to obtain and review this documentation in preparation for the preapproval inspection. On February 5, Collazo sent an email to Eric Acevedo and Marisol Cordero, two Bristol-Myers scientists who had been assigned to perform laboratory tests and other technical duties related to the production of Atazanavir. Collazo's email stated: The FDA has requested a visit to our facilities regarding the approval of Atazanavir. In order to be ready for this visit, I am requesting the transfer at least of a copy of all the technical documents regarding this process. And I also requesting all the information and documentation (such as lab notebook) regarding use test and vendor qualification. This needs to be accompanied with all the raw data supporting does [sic] experiment. All these information needs to be review and evaluated in conjunction with QA in order to prepare for this important visit. These requested information can be provided to me at your earliest convenience. I would like to thank you in advance for your support. On February 14, Collazo sent a follow-up email to López, who had been copied on the earlier message, stating that he had not received any proper response from Acevedo or Cordero and that it was very important that this information is evaluated and strategically studied well prior [to] any visit from the FDA for a PAI [preapproval inspection], in order to be ready. He asked López for assistance in obtaining the requested information. Sometime later, Collazo spoke directly with Cordero, who told him that she had spoken to López and would deliver the requested data to him the following Monday, February 23. Collazo never received this information, as he was terminated on February 21. The FDA conducted its preapproval inspection of the Barceloneta plant in May 2003. Collazo admitted in deposition that the FDA did not request any specific documents or data in advance of the preapproval inspection and that he did not know whether the FDA ever requested the information he had sought from Acevedo and Cordero.