# FDA 483 - BioLyte Laboratories, LLC - April 24, 2023

Source: https://www.keypedia.com/records/483/biolyte-laboratories-llc/11ddab1f-8bf2-4075-bf6d-b379b5a2fcd0

> FDA 483 for BioLyte Laboratories, LLC on April 24, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BioLyte Laboratories, LLC
- Inspection Date: 2023-04-24
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of BioLyte Laboratories, LLC in Grand Rapids, MI, revealed significant deficiencies in their manufacturing and quality control processes for drug products. The firm failed to conduct proper component identification, maintain an adequate stability program, and prevent objectionable microorganisms in non-sterile products. Additionally, the inspection cited issues with laboratory controls, the investigation of out-of-specification events, and the establishment of production and process controls.

## Related Documents

- [483 - 2019-12-18](https://www.keypedia.com/records/483/biolyte-laboratories-llc/c1601f74-d656-400b-a68b-0ede9c866964)
- [WARNING_LETTER - 2019-12-18](https://www.keypedia.com/records/warning_letter/biolyte-laboratories-llc/45eb4a5d-f81a-4182-8f5e-d1d033bb1eea)
- [483 - 2025-09-12](https://www.keypedia.com/records/483/biolyte-laboratories-llc/c2b2d367-405d-4840-85b1-3a8065a6551d)

## Related Officers

- [Joohi Castelvetere](https://www.keypedia.com/people/joohi-castelvetere/2340bef8-5105-4f40-9713-120196b70d82)
- [Consumer Safety Officer/ Federal Investigator](https://www.keypedia.com/people/lisa-l-flores/465a6807-55d7-4c3f-a415-c21ac4517bc9)

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