FDA Inspection
New England Life Care, Inc. dba Advanced Compounding SolutionsNew England Life Care, Inc. dba Advanced Compounding Solutions – FDA Inspection, Apr 28, 2022
Record Details
This FDA Inspection record concerns New England Life Care, Inc. dba Advanced Compounding Solutions, with an inspection on April 28, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- April 28, 2022
- Product Type
- Drugs
View Company Profile
ID · 29ec7e6c-c0bd-41b4-b17e-b1c483067460
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1168143
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Enforcement
- Warning Letter
FDA Citations
7- 21 CFR 211.42(c)(10)(iii)Air Supply
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.134(b)Representative samples after completion
- Drug product label, outsourcer facility
- 21 CFR 211.192Investigations of discrepancies, failures
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Other FDA inspections of New England Life Care, Inc. dba Advanced Compounding Solutions
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 22, 2017 | Not classified | New England District Office | Drug Quality Assurance |
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