# FDA 483 - BioLyte Laboratories, LLC - December 18, 2019

Source: https://www.keypedia.com/records/483/biolyte-laboratories-llc/c1601f74-d656-400b-a68b-0ede9c866964

> FDA 483 for BioLyte Laboratories, LLC on December 18, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BioLyte Laboratories, LLC
- Inspection Date: 2019-12-18
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: BioLyte Laboratories, LLC in Grand Rapids, MI, was inspected and received a Form 483 with ten observations, many of which were repeat findings from a previous inspection. The inspection revealed significant deficiencies across quality control, training, production records, change control, product testing, supplier management, stability testing, data review, laboratory facilities, and equipment cleaning. These issues indicate a systemic lack of adherence to current Good Manufacturing Practices.

## Related Documents

- [WARNING_LETTER - 2019-12-18](https://www.keypedia.com/records/warning_letter/biolyte-laboratories-llc/45eb4a5d-f81a-4182-8f5e-d1d033bb1eea)
- [483 - 2023-04-24](https://www.keypedia.com/records/483/biolyte-laboratories-llc/11ddab1f-8bf2-4075-bf6d-b379b5a2fcd0)
- [483 - 2025-09-12](https://www.keypedia.com/records/483/biolyte-laboratories-llc/c2b2d367-405d-4840-85b1-3a8065a6551d)

## Related Officers

- [Investigator](https://www.keypedia.com/people/charles-l-zhou/b55d1247-06de-4c7e-80d8-5ed2f801d259)

Company: https://www.keypedia.com/companies/biolyte-laboratories-llc/72aab89c-4774-4dcb-9daa-42d74b544922

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0