# FDA 483 - Applied Consumer Services Inc. - February 21, 2020

Source: https://www.keypedia.com/records/483/applied-consumer-services-inc/dd3d8795-e4ea-4186-a652-b146e09c4c2b

> FDA 483 for Applied Consumer Services Inc. on February 21, 2020. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Applied Consumer Services Inc.
- Inspection Date: 2020-02-21
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Applied Consumer Services Inc. in Hialeah Gardens, FL, a contract test laboratory, received a Form 483 for significant deficiencies in their quality control system. The firm failed to thoroughly review unexplained discrepancies and out-of-specification (OOS) results, lacking scientific justification and proper documentation in multiple investigations. Additionally, laboratory personnel did not adhere to written analytical methods, with unrecorded and unjustified deviations from established procedures.

## Related Documents

- [483 - 2025-09-29](https://www.keypedia.com/records/483/applied-consumer-services-inc/f3c3a713-94a7-428a-89bb-267c52d65f1c)

## Related Officers

- [Vivin George](https://www.keypedia.com/people/vivin-george/0b0ee298-a577-4bee-b18e-42da0c3bb148)
- [Jennifer Lalama](https://www.keypedia.com/people/jennifer-lalama/5ebc4da1-62ac-4b15-89a8-e18b0606e0ff)

Company: https://www.keypedia.com/companies/applied-consumer-services-inc/04d6a6af-783b-4c67-bb1d-d281131c548e

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6