Two regulatory inspections were reported recently. One was an FDA inspection of a Sponsor/Manufacturer. The other was an EPA inspection of a Field Contract Research Company.

The FDA inspection was a directed GLP inspection and included both data and facility audits. No prior notice was given. Two inspectors conducted the inspection. The inspection lasted eight days. One active and two completed studies were audited. An FDA Chemist participated in the evaluation of the bioanalytical labs and data. In-process dosing, blood collection, and necropsy were observed in the toxicology and pathology areas of the facility. Procedures for Sponsor oversight of the Study Monitor for contracted GLP work were inspected. The inspectors focused on documentation of communications between the Study Monitor and Study Director during the in-life phase of the study.

The submitter recommended that facilities have SOP's for monitoring contracted GLP work. Additionally, have procedures for keeping phone logs, e-mail, trip reports, etc. for documentation of communication between the Study Director and Study Monitor. They also recommended that programs be in place for evaluating animals and monitoring animal quality.

The EPA inspection was a routine inspection and included data, the facility and test site. Thirteen days notice was given. The inspection was conducted by one inspector and lasted two days. One active and three completed studies were audited. The inspectors focused on test substance characterization and proof of the % A.I., SOP's used during the conduct of the study, and application equipment use logs.

The submitter suggested that someone be available for answering questions as they come up to quickly clear up confusion. They also recommended that files be organized so data can be retrieved quickly. Lastly, they suggested that inspectors be treated with respect since they are scientists first and inspectors second.

I would like to thank the two people who submitted inspection reports.

If you have had a recent inspection, please send your inspection experiences to Sherita Normington. FAX (916) 481-2959 or telephone (916) 481-3141. The questionnaire is included in your newsletter, or can be found online.

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