# FDA EIR - Dr. K.R. Raveendra - December 15, 2017

Source: https://www.keypedia.com/records/eir/dr-kr-raveendra/becab62f-ff42-46cd-aab8-afb630c0fdba

> FDA EIR for Dr. K.R. Raveendra on December 15, 2017. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: Dr. K.R. Raveendra
- Inspection Date: 2017-12-15
- Product Type: Drugs
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Dr. K.R. Raveendra, M.D., a clinical investigator at Bangalore Medical College and Research Institute in Bangalore, India, took place from December 11 to December 15, 2017. This was the first FDA inspection of this investigator, conducted under the regulatory framework of CP 7348.811 for Clinical Investigators. The primary purpose was to review records for AstraZeneca's Phase III clinical study (D4281C00001) evaluating Ceftazidime-Avibactam against Meropenem for Nosocomial Pneumonia. The inspection encompassed a comprehensive review of study administration, ethics committee approvals, subject selection and informed consent procedures, study drug accountability, source data verification, adverse event reporting, protocol adherence, financial disclosures, and site monitoring. Notably, the inspection concluded without identifying any significant problems or issuing an FDA Form 483, Inspectional Observations. Reviewers found no evidence of deliberate non-reporting or under-reporting of adverse events. A minor observation noted two concomitant medications in medical notes that were not in data listings, although they were captured in a separate log. Management was cooperative, and no refusals were encountered. As no significant issues were identified, no specific corrective actions were formally required by the FDA following this inspection.

## Related Officers

- [investigator](https://www.keypedia.com/people/k-raveendra/a6dee213-2c29-4d4f-a398-04ddf0cc48f8)
- [issuing_officer](https://www.keypedia.com/people/myla-d-chapman/ef32fed3-5cfc-42ed-b421-cbc83fd548a4)
- [investigator](https://www.keypedia.com/people/prabhu-subramani/f7e11015-5751-4d14-b790-7263378c1031)

Company: https://www.keypedia.com/companies/dr-kr-raveendra/c86b6fd4-6cb3-49f0-85f4-8a8c6502d3c0

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7