# FDA 483 - Ol Pharma Tech LLC - July 22, 2024

Source: https://www.keypedia.com/records/483/ol-pharma-tech-llc/0b3c64e4-feb8-4b26-a3f7-726155f8090d

> FDA 483 for Ol Pharma Tech LLC on July 22, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ol Pharma Tech LLC
- Inspection Date: 2024-07-22
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Ol Pharma Tech LLC received a Form 483 citing significant deficiencies across its quality system, laboratory controls, and manufacturing processes. The inspection revealed a lack of an independent quality control unit, unwritten and unapproved procedures, and inadequate testing for product stability and microbial contamination. The firm also failed to validate manufacturing processes, maintain proper batch records, and provide essential employee training.

## Related Officers

- [Joohi Castelvetere](https://www.keypedia.com/people/joohi-castelvetere/2340bef8-5105-4f40-9713-120196b70d82)
- [Nicholas J. Presto](https://www.keypedia.com/people/nicholas-j-presto/2ecdd573-6662-4d07-b93c-ddb9c603bcfa)

Company: https://www.keypedia.com/companies/ol-pharma-tech-llc/7a079e83-9ffa-4c66-b8af-b204942fed6b

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