# FDA 483 - Lusys Laboratories, Inc. - September 24, 2021

Source: https://www.keypedia.com/records/483/lusys-laboratories-inc/e6a45b80-b07f-4380-b023-468bd7142dd6

> FDA 483 for Lusys Laboratories, Inc. on September 24, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lusys Laboratories, Inc.
- Inspection Date: 2021-09-24
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Lusys Laboratories, Inc. in San Diego, CA, received a Form 483 with four observations during an FDA inspection. The firm was cited for failing to validate manufacturing processes for COVID-19 test strips and for not establishing adequate procedures to control environmental conditions for finished products. Additionally, the inspection revealed deficiencies in the firm's corrective and preventive action (CAPA) system and a failure to maintain complete distribution records for medical devices.

## Related Documents

- [WARNING_LETTER - 2015-05-15](https://www.keypedia.com/records/warning_letter/lusys-laboratories-inc/8f44cfc5-6e7b-4d05-a605-2a283cf063c1)
- [WARNING_LETTER - 2021-09-24](https://www.keypedia.com/records/warning_letter/lusys-laboratories-inc/5b81b74e-a5c5-4a73-98ec-969d6153265a)

## Related Officers

- [Consultant](https://www.keypedia.com/people/seema-singh/7f3f7209-1749-46ee-8829-f305c5512e38)

Company: https://www.keypedia.com/companies/lusys-laboratories-inc/348b7ce4-cdf8-44e0-abf5-ff62a64182ac

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