FDA Inspection
Baxter Hospitalar LtdaBaxter Hospitalar Ltda – FDA Inspection, May 18, 2018
Record Details
This FDA Inspection record concerns Baxter Hospitalar Ltda, with an inspection on May 18, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 25dd130a-d63c-4455-8f15-69095071e197
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1052824
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.188(a)Accurate reproduction
- 21 CFR 211.48(a)Plumbing System Defects
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