# FDA 483 - First Time US Generics LLC - February 15, 2018

Source: https://www.keypedia.com/records/483/first-time-us-generics-llc/5a6a5275-a854-4678-af2c-c91fec5eaee6

> FDA 483 for First Time US Generics LLC on February 15, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: First Time US Generics LLC
- Inspection Date: 2018-02-15
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: During an FDA inspection, First Time US Generics LLC in Broomall, PA, was cited for deficiencies in their equipment cleaning and maintenance procedures. The firm lacked written procedures for documenting quality issues related to maintenance, as evidenced by an unassessed damaged tablet press. This indicates a failure in maintaining equipment in a state of control and ensuring product quality.

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## Related Officers

- [Investigator](https://www.keypedia.com/people/craig-d-zagata/1e9614e4-4efe-4d11-8b85-9fd43b64d40c)

Company: https://www.keypedia.com/companies/first-time-us-generics-llc/f6359b6c-cd28-4749-a4da-8187845004bf

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8