# FDA 483 - Biomedics Systems Inc - October 04, 2019

Source: https://www.keypedia.com/records/483/biomedics-systems-inc/ed626dd1-6dc0-40df-9cd9-f6b0ca0a0175

> FDA 483 for Biomedics Systems Inc on October 04, 2019. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Biomedics Systems Inc
- Inspection Date: 2019-10-04
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: BIOMEDIC SYSTEMS INC., a medical gas transfiller in San Juan, PR, was cited for a significant deficiency in quality control during an FDA inspection. The firm failed to document required tests for empty cylinders, which are components for medical gas, before accepting them for use. This lapse resulted in the release of medical gas lots without proper verification that the components conformed to specifications.

## Related Officers

- [investigator](https://www.keypedia.com/people/marian-e-ramirez/4b718b67-fee0-488c-9354-ee366d3510ad)

Company: https://www.keypedia.com/companies/biomedics-systems-inc/d34656c6-79a8-4015-bbe0-7932fb59a352

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-iv/a8c8fd15-4e7a-46cb-903a-9980f7ea89e6