Inspection Record

New England Life Care, Inc., dba Advanced Compounding Solutions — FDA 483 Findings

US FDAInspected 2018-02-02Published 2024-01-17 6 findingsLaboratory and QC controlsAseptic processing and sterility assuranceMaterial and supplier controlEquipment and facilityComplaint and recall handling

Inspectors Robert J Martin · Erik W KoesterThe inspectors who signed the published document.Inspector lookup

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

Findings

1Laboratory and QC controls

Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications and identity and strength of each active ingredient prior to release.

2Aseptic processing and sterility assurance

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed.

3Material and supplier control

Each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.

4Aseptic processing and sterility assurance

Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.

5Equipment and facility

Equipment for adequate control over air pressme and micro-organisms is not provided when appropriate for the manufacture, processing, packing or holding of a drug product.

6Complaint and recall handling

Procedures describing the handling of all written and oral complaints regarding a drug product are not written.

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.

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Other records for this company

2017-09-29 · US FDA · 6 findings2023-05-30 · US FDA · 30 findings
New England Life Care, Inc., dba Advanced Compounding Solutions company profile — full history US FDA documents, 2024 Go to Findings search