MSD International GmbH (Puerto Rico Branch) LLC – FDA 483, Feb 26, 2020
MSD International GmbH (Puerto Rico Branch) LLC in Las Piedras, PR, was inspected regarding its drug manufacturing operations. The inspection revealed significant deficiencies in the firm's investigation processes for unexplained discrepancies and batch failures, as these investigations did not adequately extend to other affected batches. Additionally, the firm failed to submit required Field Alert Reports to the FDA within the mandated three working days for multiple distributed drug batches that did not meet specifications.
- Inspection date
- February 26, 2020
- Product type
- drugs
ID · 4cf5af1d-3272-4d14-b1f4-1c3b62f2a5ba
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