# FDA 483 - Spray-Tek LLC - August 17, 2022

Source: https://www.keypedia.com/records/483/spray-tek-llc/5a6bfebd-2bfa-46e1-9385-3a23d86c5779

> FDA 483 for Spray-Tek LLC on August 17, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Spray-Tek LLC
- Inspection Date: 2022-08-17
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: Spray-Tek, LLC, a contract manufacturer in Bethlehem, PA, was inspected and cited for failing to adequately investigate environmental monitoring excursions. The firm did not identify root causes or corrective actions, conduct product impact risk assessments, or evaluate these findings prior to releasing affected batches. This indicates significant deficiencies in their quality control and investigation processes.

## Related Officers

- [Michele Gottshall](https://www.keypedia.com/people/michele-gottshall/f12dcaf7-8958-4591-88bb-f9746796b934)

Company: https://www.keypedia.com/companies/spray-tek-llc/1f86c217-9f4c-4df2-8d2f-345cb6e62501

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