FDA Inspection
New England Life Care, Inc.New England Life Care, Inc. – FDA Inspection, Feb 8, 2018
Record Details
This FDA Inspection record concerns New England Life Care, Inc., with an inspection on February 8, 2018, issued by the New England District Office, covering human drugs.
- People
- Abhishek Sahay (Issuing Officer)
- Margaret M. Doherty (Issuing Officer)
- Robert J. Martin
View Company Profile
ID · 27ea0042-0aea-4d80-8ba9-8fd0fda66b93
Inspection Facts
- Inspection number
- 1040234
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- FDCA 501(a)(2)(A)Beta-lactam drugs, inadequate sanitation
- FDCA 501(a)(2)(A)Disinfecting and cleaning agents, ISO 5 area
- FDCA 501(a)(2)(A)Disruption of airflow from personnel movement
- FDCA 501(a)(2)(A)Inadequate HEPA filter, sterile product area
- FDCA 501(a)(2)(A)Non-microbial contamination, production area
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.