FDA Inspection 1168143 — New England Life Care, Inc.
The FDA completed an inspection of New England Life Care, Inc. on Apr 28, 2022 in Woburn, MA. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Apr 28, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Woburn, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1433 | 21 CFR 211.42(c)(10)(iii) | Air Supply |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1724 | 21 CFR 211.134(b) | Representative samples after completion |
| 18008 | FDCA 503B(a)(10) | Drug product label, outsourcer facility |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |