# Laboratorios Quantium Llc – FDA Inspection, Aug 2, 2018

Source: https://www.keypedia.com/records/fda_inspections/laboratorios-quantium-llc/5246d351-0d7d-4b53-9ef4-0129932a8ed2
Source feed: FDA_Inspections

> FDA inspection 1060811 of Laboratorios Quantium Llc, August 02, 2018. Classification: Official Action Indicated (OAI). 10 citations under 21 CFR part 211. Form 483 issued.

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## Details

- Record Type: FDA Inspection
- Inspection ID: 1060811
- Company Name: Laboratorios Quantium Llc
- Inspection Date: 2018-08-02
- Classification: Official Action Indicated (OAI)
- Classification Code: OAI
- Project Area: Drug Quality Assurance
- Product Type: Drugs
- Center: Human Drugs
- Office Name: Center for Drug Evaluation and Research
- Citation Count: 10
- Enforcement Type: WARNING_LETTER

## Related Officers

- [FDA Associated Person](https://www.keypedia.com/people/jennifer-lalama/5ebc4da1-62ac-4b15-89a8-e18b0606e0ff)
- [Company Rep](https://www.keypedia.com/people/rozelle-g-smith/cd2488c0-fe18-4fc4-a80e-20d08a8d12cc)

Company: https://www.keypedia.com/companies/laboratorios-quantium-llc/4bc6e504-fe88-4b4f-b332-adde406042c9

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c