1Equipment and facility
Equipment used is not of adequate size to facilitate operations for its intended use or for cleaning and maintenance.
Inspection Record
Emergent Manufacturing Operations Baltimore, LLC. — FDA 483 Findings
Inspectors Debra M. Emerson · Cody D. RickmanThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
The building used for the manufacture of the client <Redacted B4> viral vaccine drug substance and client <Redacted B4> viral vaccine drug substance is not of suitable size, design and location to facilitate cleaning, maintenance, and proper operations.
3Equipment and facility
Written procedures designed to assure that the drug substances manufactured in the facility have the identity, strength, quality, and purity they purport or are represented to possess are inadequate.
4Equipment and facility
Equipment and/or utensils are not cleaned and maintained al appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug substance.
5Equipment and facility
The building used for the manufacture of the client <Redacted B4> viral vaccine drug substance and client <Redacted B4> viral vaccine drug substance is not maintained in a clean and sanitary condition.
6Material and supplier control
The components, product containers and/or closures were not handled and/or stored in a manner to prevent contamination.
7Process validation
Written production and process control procedures to prevent cross-contamination are not followed in the execution of production and process control functions and are not documented at the time of performance.
8Other quality system
Employees were not trained in the particular operation that they performed and/or in CG MPs related to their job function.
About this record
Extracted automatically from the document US FDA published on 2021-05-13. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
