# American Contract Systems Inc. – FDA 483, Sep 24, 2021

Source: https://www.keypedia.com/records/483/american-contract-systems-inc/10fa68d4-68f2-4d14-b3ba-528dbb25ca4d

> FDA 483 for American Contract Systems Inc. on September 24, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: American Contract Systems Inc.
- Inspection Date: 2021-09-24
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: An FDA inspection of American Contract Systems Inc. in Grimes, IA, a contract sterilizer and manufacturer, revealed significant deficiencies in their quality system. Observations included inadequate procedures for handling nonconforming product, insufficient process controls for gas injection sterilization, and a lack of equipment maintenance logs. Additionally, the firm failed to establish proper controls for labeling activities, indicating a broad pattern of procedural shortcomings.

## Related Officers

- [Edward E. Lockwood](https://www.keypedia.com/people/edward-e-lockwood/3260b39e-9211-489f-8247-0ec3353e57ca)
- [Clifford F. Long](https://www.keypedia.com/people/clifford-f-long/846e5a0c-cb7c-421c-86aa-be9fddfbaaba)

Company: https://www.keypedia.com/companies/american-contract-systems-inc/c8a870aa-4c97-4471-9faf-c32500c8a82d

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8