# FDA 483 - A. R. Hinkel Company, Inc. dba R.A.Fischer - January 24, 2020

Source: https://www.globalkeysolutions.net/records/483/a-r-hinkel-company-inc-dba-rafischer/76b6ce6c-c797-4b55-a145-3e9ab00ae504

> FDA 483 for A. R. Hinkel Company, Inc. dba R.A.Fischer on January 24, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: A. R. Hinkel Company, Inc. dba R.A.Fischer
- Inspection Date: 2020-01-24
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: A. R. Hinkel Company, Inc. dba F.A. Flechog, a medical device manufacturer in Simi Valley, CA, was cited with two observations during an FDA inspection. The observations highlight deficiencies in process validation for soldering and inadequate procedures for controlling and documenting nonconforming products. These issues indicate a need for improved adherence to quality system requirements.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/sarah-a-hassas/4f142d54-fc28-4bd5-82ad-7e6fa443688c)

Company: https://www.globalkeysolutions.net/companies/a-r-hinkel-company-inc-dba-rafischer/3383d00c-e8b8-41a2-9866-414d47c338be

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