FDA EIR - Merck Sharp & Dohme LLC - October 30, 2018

An FDA cGMP surveillance inspection of Merck Sharp & Dohme Corp.'s Durham, NC facility occurred from October 22-30, 2018. The inspection covered the manufacture and testing of licensed biological products, including Varivax\[U+00AE\] and M-M-R\[U+00AE\]II vaccines and Varicella Bulk Drug Substance, under the current Good Manufacturing Practice (cGMP) regulatory framework (21 CFR 211.113(b) and Section 501(a)(2)(B) of the Act).

The inspection resulted in a Form FDA 483 with four key observations. These included: (1) inadequate procedures to prevent microbiological contamination of sterile drug products, citing a lack of physical evidence on personnel monitoring plates, observed poor aseptic techniques by operators (e.g., gloved hands touching gowns, gowns contacting equipment, non-deliberate movement, and improper trash handling in cleanrooms), and insufficient controls for unidirectional personnel flow between graded areas. Additional observations cited (2) unestablished or unfollowed procedures for handling drug product complaints, (3) failure to thoroughly review unexplained discrepancies regardless of batch distribution, and (4) failure to submit biological deviation reports.

Merck Sharp & Dohme Corp. management committed to providing a written response to the Agency addressing these observations within 15 business days.