# FDA 483 - Arkema, Inc. - September 22, 2021

Source: https://www.keypedia.com/records/483/arkema-inc/f2ea83d8-3e06-47ca-9cbf-5943451242b1

> FDA 483 for Arkema, Inc. on September 22, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Arkema, Inc.
- Inspection Date: 2021-09-22
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Arkema, Inc. in Piffard, NY, an API manufacturer, received a Form 483 for significant deficiencies observed during an FDA inspection. The firm was cited for inadequate cleaning validation practices, failing to conduct trace analysis or challenge hard-to-clean areas, and relying solely on visual inspection. Additionally, the inspection revealed deficiencies in annual product review procedures, which did not include a review of complaint and investigation records, and a failure to establish and follow written procedures for the quality control unit's complaint handling, leading to inconsistent and delayed investigations.

## Related Officers

- [Johnna L. Bleem](https://www.keypedia.com/people/johnna-l-bleem/3fe669bf-e354-4cdc-9337-d5ceb23f1c9f)

Company: https://www.keypedia.com/companies/arkema-inc/a578e595-0193-4499-849a-bfcff4ad9bb5

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