# FDA 483 - Analytical Control Systems, Inc - December 19, 2019

Source: https://www.keypedia.com/records/483/analytical-control-systems-inc/32cd3bde-7b26-43b4-8fbc-d2f7ac51b7d1

> FDA 483 for Analytical Control Systems, Inc on December 19, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Analytical Control Systems, Inc
- Inspection Date: 2019-12-19
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Analytical Control Systems, Inc. in Fishers, IN, a manufacturer of blood-based calibrators and controls, received a Form FDA 483 citing four observations. The inspection revealed significant deficiencies in process validation, equipment maintenance, internal quality audits, and formal management review procedures. These issues indicate a lack of adequate quality system controls at the facility.

## Related Documents

- [WARNING_LETTER - 2013-12-03](https://www.keypedia.com/records/warning_letter/analytical-control-systems-inc/2424f7f3-c7f9-4a78-a971-9f22f34da4d2)

## Related Officers

- [Debara R. Reese](https://www.keypedia.com/people/debara-r-reese/277a8fbb-ba4d-4402-be08-16d7977685db)

Company: https://www.keypedia.com/companies/analytical-control-systems-inc/f7ebb9b2-7edd-4a4c-95ec-90c5e2a06e2f

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0