FDA Inspection 1040234 — New England Life Care, Inc.
The FDA completed an inspection of New England Life Care, Inc. on Feb 8, 2018 in Woburn, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 8, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Woburn, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18936 | FDCA 501(a)(2)(A) | Non-microbial contamination, production area |
| 18937 | FDCA 501(a)(2)(A) | Beta-lactam drugs, inadequate sanitation |
| 18948 | FDCA 501(a)(2)(A) | Disruption of airflow from personnel movement |
| 18963 | FDCA 501(a)(2)(A) | Inadequate HEPA filter, sterile product area |
| 18970 | FDCA 501(a)(2)(A) | Disinfecting and cleaning agents, ISO 5 area |