# FDA 483 - Pharmaloz Manufacturing Inc. - June 21, 2018

Source: https://www.keypedia.com/records/483/pharmaloz-manufacturing-inc/4495165a-cd9a-4248-a611-68d981978daa

> FDA 483 for Pharmaloz Manufacturing Inc. on June 21, 2018. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Pharmaloz Manufacturing Inc.
- Inspection Date: 2018-06-21
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: Pharmaloz Manufacturing Inc. in Lebanon, PA, a drug manufacturer, was inspected and cited for multiple significant deficiencies. The inspection revealed issues including inadequate investigations into out-of-specification results, poor laboratory data integrity controls (a repeat observation), insufficient employee training, and improper storage conditions for drug products. These findings indicate a moderate level of non-compliance with good manufacturing practices.

## Related Officers

- [Investigator](https://www.keypedia.com/people/junho-pak/4abe53fb-ad20-490d-9e71-6216a9f863f5)

Company: https://www.keypedia.com/companies/pharmaloz-manufacturing-inc/a50b03f7-302e-439f-a910-5696712ac40a

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