Smithers Pharmaceutical Development Services Llc

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of written procedures, the laboratory director did not document their review and approval of written procedures. Findings: 1. Approval of procedures and changes to procedures is the responsibility of the laboratory director. This responsibility cannot be delegated. 2. The review and approval of the written procedure to measure neutralizing antibodies in human serum was delegated to the product manager. The documentation showing approval of the written procedure did not show the laboratory director's review and approval. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on record review and interview with the laboratory director, the laboratory director did not provide documentation to verify the discipline of graduate study completed, for one of six technical supervisors, credentialed by the surveyor on the day of survey. Findings: 1. The laboratory provided the diploma and curriculum vitae of staff to show that they meet educational and experience requirements to perform their duties as technical supervisor; 2. The diploma for one of six technical supervisors evaluated did not name the discipline of study on the diploma. The curriculum vitae was used to identify the discipline; and 3. The laboratory director reported, during interview on the day of survey, that their was no other record to verify the field of study for the technical supervisor. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --