# FDA 483 - Gordon Laboratories Inc - March 10, 2022

Source: https://www.keypedia.com/records/483/gordon-laboratories-inc/f9522916-3ee5-47bd-a1f4-c37a74066874

> FDA 483 for Gordon Laboratories Inc on March 10, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Gordon Laboratories Inc
- Inspection Date: 2022-03-10
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Gordon Laboratories Inc, an OTC drug manufacturer in Carson, CA, was cited with six observations during an FDA inspection. The firm demonstrated significant deficiencies in its quality control unit, including inadequate investigations into contaminated hand sanitizer and failures in water system management. Additionally, the company lacked proper stability data for its drug products and had insufficient laboratory controls.

## Related Documents

- [WARNING_LETTER - 2022-03-10](https://www.keypedia.com/records/warning_letter/gordon-laboratories-inc/cca36100-f5bf-4c05-8dac-a8068967aae1)

## Related Officers

- [Joel D. Hustedt](https://www.keypedia.com/people/joel-d-hustedt/29440042-08dd-4dce-be48-b55f8e1d7080)
- [issuing_officer](https://www.keypedia.com/people/gavin-t-cua/6f498dd6-2c4b-42e9-8ddc-3c2a7c97afef)

Company: https://www.keypedia.com/companies/gordon-laboratories-inc/b34d0f42-2eba-4655-81d4-9e99541b4770

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