# FDA 483 - Laboratorios Labocont Industrial SRL - June 05, 2017

Source: https://www.globalkeysolutions.net/records/483/laboratorios-labocont-industrial-srl/baecb0d9-34ff-488e-a92a-9a43b4de9d22

> FDA 483 for Laboratorios Labocont Industrial SRL on June 05, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Laboratorios Labocont Industrial SRL
- Inspection Date: 2017-06-05
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Labocont Industrial SRL, a human drug and OTC manufacturer in Santo Domingo, Dominican Republic, was inspected by the FDA. The inspection revealed significant deficiencies across its manufacturing processes for OTC ointment products, including a lack of written procedures, process validation, stability studies, and proper maintenance of critical systems. Furthermore, the firm failed to validate analytical methods, maintain complete batch and laboratory records, ensure equipment cleanliness, and provide adequate GMP training to employees.

## Related Documents

- [WARNING_LETTER - 2017-06-09](https://www.globalkeysolutions.net/records/warning_letter/laboratorios-labocont-industrial-srl/0b1c29e2-a66a-4d83-b98b-c2698a0d587c)

## Related Officers

- [Quality System Specialist](https://www.globalkeysolutions.net/people/jose-e-melendez/75bd6083-14a4-4bd2-a0e5-9946d4dd37e1)

Company: https://www.globalkeysolutions.net/companies/laboratorios-labocont-industrial-srl/fc77badb-cf3a-4fa4-b6c2-c29f745414ee

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd