# FDA 483 - WHPM Inc. - February 28, 2022

Source: https://www.globalkeysolutions.net/records/483/whpm-inc/0f3ab778-a4c9-4552-8fb0-ad0de5a1871c

> FDA 483 for WHPM Inc. on February 28, 2022. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: WHPM Inc.
- Inspection Date: 2022-02-28
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: W.H.P.M., Inc. in Irwindale, CA, a medical device manufacturer, was cited with four observations on a Form 483 following an FDA inspection. The firm demonstrated significant deficiencies in establishing product identification procedures for export-only SARS-CoV-2 Antigen Test Kits, maintaining adequate complaint files, documenting acceptance of incoming products, and properly maintaining quality system records, specifically employee training records. These issues collectively indicate a lack of adherence to quality system requirements and proper documentation practices.

## Related Documents

- [483 - 2022-11-18](https://www.globalkeysolutions.net/records/483/whpm-inc/d133d145-e241-4cf8-9079-24fbf985aca7)
- [483 - 2024-01-30](https://www.globalkeysolutions.net/records/483/whpm-inc/86a19d42-9140-4b3b-906a-65aac56b0c85)

## Related Officers

- [Sonya L. Korsak](https://www.globalkeysolutions.net/people/sonya-l-korsak/167a5b7d-6b4e-4cd0-ad31-03db6ea31a49)
- [Terri E. Gibson](https://www.globalkeysolutions.net/people/terri-e-gibson/f1a80f95-a5c4-4cae-9a4b-e23f367770bb)

Company: https://www.globalkeysolutions.net/companies/whpm-inc/713384b0-f0ac-4ea2-8216-fc8b0910359b

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6