1Other quality system
Aforementioned cited 5 Certificates of Analysis were all received by 01 September 2017.
Inspection Record
New England Life Care, Inc., dba Advanced Compounding Solutions — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Material and supplier control
Each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.
3Regulatory reporting and change control
Policies PP 04‐01, Member Grievance and PP 04‐07, Major Incident Response Plan will be updated in accordance with Adverse Event Reporting for Outsourcing Facilities under Section 503B of the Federal Food, Drug and Cosmetic Act, Guidance for Industry.
4Complaint and recall handling
Procedures describing the handling of all written and oral complaints regarding a drug product are not written.
5Other quality system
All five cited COAs have been obtained and all meet the standard set forth in the 483.
6Aseptic processing and sterility assurance
The firm will update the Laminar Flow Hood Operation and Maintenance policy, PP 05‐33 as well as the competency assessment sterile aseptic technique, PP 05‐01B.
About this record
Extracted automatically from the document US FDA published on 2024-01-17. 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.
