# FDA 483 - PARAFFIN USA LLC - February 22, 2022

Source: https://www.globalkeysolutions.net/records/483/paraffin-usa-llc/a2bf71e2-cc88-4007-9628-eed08be551fc

> FDA 483 for PARAFFIN USA LLC on February 22, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PARAFFIN USA LLC
- Inspection Date: 2022-02-22
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of PARAFFIN USA LLC, a medical device manufacturer in Phoenix, AZ, revealed three significant quality system deficiencies. The firm failed to maintain proper records for complaint investigations, lacked adequate procedures for sampling methods, and did not document supplier evaluations as required by its own standard operating procedures. These observations indicate a need for improved adherence to quality system regulations.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/charles-l-larson/4232255d-bfd6-4616-a854-c801e4c23e1c)

Company: https://www.globalkeysolutions.net/companies/paraffin-usa-llc/212d828f-7569-4cab-8d6b-6685da6abf17

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