# FDA 483 - Henry Okonkwo, P.A. - July 01, 2018

Source: https://www.globalkeysolutions.net/records/483/henry-okonkwo-pa/9b4b99b0-0fb5-42f4-acf0-6cb67b31bc8e

> FDA 483 for Henry Okonkwo, P.A. on July 01, 2018. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Henry Okonkwo, P.A.
- Inspection Date: 2018-07-01
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Henry Okonkwo, P.A. in Los Angeles, CA, a clinical investigator, revealed a significant issue with incomplete subject case histories. The firm failed to maintain source documentation for specialist assessments, reportedly destroying these documents after e-CRF entry as instructed by a monitor. This practice resulted in e-CRF entries with audit trail timestamps indicating data entry occurred days after subject visits, rather than direct entry.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/travis-m-beard/a89f6d0b-dc5b-4adc-84f5-36e04b00fc2d)

Company: https://www.globalkeysolutions.net/companies/henry-okonkwo-pa/a0d93495-dcfe-4be1-8c2b-03e46e3f0adb

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6