# FDA 483 - Verichem Laboratories, Inc. - May 24, 2022

Source: https://www.globalkeysolutions.net/records/483/verichem-laboratories-inc/3b7c1189-cb14-4bd7-acc2-e238e6411e18

> FDA 483 for Verichem Laboratories, Inc. on May 24, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Verichem Laboratories, Inc.
- Inspection Date: 2022-05-24
- Product Type: device
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: An FDA inspection of Verichem Laboratories, Inc. in Providence, RI, revealed significant deficiencies across its quality management system. The firm failed to adequately establish procedures for reporting field corrections, evaluating suppliers, managing acceptance activities, calibrating equipment, controlling design changes, and handling customer complaints. These observations indicate a need for comprehensive improvements to ensure compliance with regulatory requirements.

## Related Documents

- [WARNING_LETTER - 2014-11-14](https://www.globalkeysolutions.net/records/warning_letter/verichem-laboratories-inc/8feb0279-eb95-40fa-bed6-f5194dc72c0a)

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/maryam-tabatabaie/b792042d-e296-446d-90a9-d30c8f635506)

Company: https://www.globalkeysolutions.net/companies/verichem-laboratories-inc/02e91134-b580-4692-a951-a0c3e7a85874

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7