FDA Inspection
New England Life Care, Inc.New England Life Care, Inc. – FDA Inspection, Mar 2, 2018
Record Details
This FDA Inspection record concerns New England Life Care, Inc., with an inspection on March 2, 2018, issued by the New England District Office, covering human drugs.
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ID · 112b2729-7871-4243-812d-47c5281c9e21
Inspection Facts
- Inspection number
- 1043176
- 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)Disinfecting materials, aseptic processing area
- FDCA 501(a)(2)(A)Exposure of personnel in aspectic processing
- FDCA 501(a)(2)(A)Inadequate HEPA filter, sterile product area
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