FDA Inspection
New England Life Care, Inc. dba Advanced Compounding SolutionsNew England Life Care, Inc. dba Advanced Compounding Solutions – FDA Inspection, Aug 22, 2017
Record Details
This FDA Inspection record concerns New England Life Care, Inc. dba Advanced Compounding Solutions, with an inspection on August 22, 2017, issued by the New England District Office, covering human drugs.
- Inspection Date
- August 22, 2017
- Product Type
- Human Drugs
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ID · d4de7e56-6a27-4b85-be5d-20a2ac44ef85
Inspection Facts
- Inspection number
- 1023399
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.46(b)Equipment for Environmental Control
- 21 CFR 211.84(d)(2)Testing Each Component for Conformity with Specs
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Other FDA inspections of New England Life Care, Inc. dba Advanced Compounding Solutions
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 28, 2022 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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