Merck Sharp & Dohme LLC
Overview
Merck Sharp & Dohme LLC is a leading global biopharmaceutical company known for its innovative approach to healthcare. As a subsidiary of Merck & Co., Inc., it operates with a focus on research and development to address unmet medical needs.
Therapeutic areas
API / Drug Master Files
Merck Sharp & Dohme LLC holds 0 active (1 total) FDA Type II Drug Master File — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.
- PREPARATION OF TEN STABLE ISOTOPE-LABELLED COMPOUNDSInactive1978-01-26
FDA compliance signals
27 FDA enforcement records linked to this company.
- recall — Class II2025-12-31
Presence of particulate matter: potential presence of metal particulates in the product.
- recall — Class II2025-12-31
Presence of particulate matter: potential presence of metal particulates in the product.
- 4832024-08-23
Investigations of discrepancies, failures
- 4832024-08-23
Procedures for sterile drug products
- recall — Class II2022-04-13
Presence of foreign substance: Presence of stainless steel particulates in tablets.
- recall — Class I2021-11-10
Presence of Particulate Matter: Identified as Glass Particles
- 4832021-04-16
Calibration/Inspection/Checking not done
- 4832021-04-16
Handling and Storage to Prevent Contamination
- 4832021-04-16
Buildings not maintained in good state of repair
- 4832021-04-16
Prepared for each batch, include complete information
- 4832021-04-16
Authority lacking to review records, investigate errors
- 4832021-04-16
Absence of Written Procedures
- recall — Class II2021-01-13
Lack of assurance of sterility: The results of sterility tests of seven batches of product were out of specification. Five of these batches tested positive for Ralstonia pickettii and two batches produced turbid results that could not be further identified. While all product distributed to the market has met the registered specifications for release, including for sterility, it was manufactured on the same equipment as the affected batches.
- 4832019-06-28
Investigations of discrepancies, failures
- 4832019-06-28
Penicillin processing area not kept separate
Ready to Accelerate Your
Discovery Workflow?
Find, vet, and source drug-manufacturing partners faster — with FDA compliance screening built in. Start free for 14 days.