# FDA 483 - KP Pharmaceutical Technology - March 21, 2024

Source: https://www.keypedia.com/records/483/kp-pharmaceutical-technology/c774dd17-c5c5-4769-9d75-e5911bfefd41

> FDA 483 for KP Pharmaceutical Technology on March 21, 2024. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: KP Pharmaceutical Technology
- Inspection Date: 2024-03-21
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: KP Pharmaceutical Technology, a manufacturer in Bloomington, IN, was inspected and received nine observations primarily related to significant deficiencies in aseptic processing, environmental monitoring, and quality control. The findings indicate a lack of established and followed procedures to prevent microbiological contamination, incomplete laboratory records, and inadequate investigations into batch failures. These issues suggest a high risk to the sterility and quality of drug products.

## Related Documents

- [483 - 2023-02-03](https://www.keypedia.com/records/483/kp-pharmaceutical-technology/af93ffc6-90c2-4cba-8eba-f8fa21b7a395)
- [483 - 2024-03-11](https://www.keypedia.com/records/483/kp-pharmaceutical-technology/173fdef4-ac0a-4d24-b45a-3209f2cd0614)

## Related Officers

- [Travis V. Hull](https://www.keypedia.com/people/travis-v-hull/1f3b5843-29ed-4291-8a8a-a2bf3ac36988)
- [Investigator?](https://www.keypedia.com/people/robert-j-ham/9146e819-4fce-420c-a722-cbe14e3c6afb)
- [Investigator](https://www.keypedia.com/people/rafeeq-a-habeeb/ac58c0b7-bd42-4037-8ccb-bf0351b7744f)

Company: https://www.keypedia.com/companies/kp-pharmaceutical-technology/acd7d203-2bd2-4702-a902-83c45f57890f

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