# FDA 483 - Alliance Precision Plastics Corporation - June 04, 2021

Source: https://www.keypedia.com/records/483/alliance-precision-plastics-corporation/14af0c91-4792-42e5-87b3-b721c547ac89

> FDA 483 for Alliance Precision Plastics Corporation on June 04, 2021. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Alliance Precision Plastics Corporation
- Inspection Date: 2021-06-04
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Alliance Precision Plastics Corporation, a medical device contract manufacturer in Rochester, NY, revealed significant quality system deficiencies. Observations included inadequate software validation for production and measurement equipment, poorly established procedures for in-process product acceptance, and insufficient corrective and preventive action processes. These issues indicate a lack of robust quality controls for critical manufacturing and quality assurance activities.

## Related Officers

- [Matthew D. Schnittker](https://www.keypedia.com/people/matthew-d-schnittker/cf76f07f-db6d-47a0-8412-7eb084d4fe8b)

Company: https://www.keypedia.com/companies/alliance-precision-plastics-corporation/5daaf934-7c9a-4e32-b4f0-61af58519dde

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961