Inspection Record

Emergent Manufacturing Operations Baltimore LLC — FDA 483 Findings

US FDAInspected 2020-04-20Published 2021-04-23 5 findingsComputer system validationQuality unit oversightMaterial and supplier controlTraining and personnelLaboratory and QC controls

Inspectors Marcellinus D DordunooThe inspectors who signed the published document.Inspector lookup

View the regulator's official source The source document is always the basis for judgement.

Findings

1Computer system validation

Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel Specifically, A.

2Quality unit oversight

The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.

3Material and supplier control

Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the holding of rejected components before disposition.

4Training and personnel

Employees are not given training in the particular operations they perform as part of their function and current good manufacturing practices.

5Laboratory and QC controls

Established specifications, test procedures and laboratory control mechanisms are not followed and documented at the time of performance.

About this record

Extracted automatically from the document US FDA published on 2021-04-23. 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.

Other records for this company

2021-10-29 · EMA (Europe) · 1 findings2021-10-25 · Health Canada · 11 findings2021-04-20 · US FDA · 8 findings
Emergent Manufacturing Operations Baltimore LLC findings history — including this company's other documents US FDA documents, 2021 Go to Findings search