# FDA EIR - Gene Logic, Inc. - September 13, 2007

Source: https://www.keypedia.com/records/eir/gene-logic-inc/433b0811-302d-4e02-a074-243a825ece1a

> FDA EIR for Gene Logic, Inc. on September 13, 2007. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: Gene Logic, Inc.
- Inspection Date: 2007-09-13
- Product Type: drugs
- Summary: A comprehensive FDA inspection of Bridge Global Pharmaceutical Services Inc., a non-clinical laboratory in Gaithersburg, MD, was conducted from August 30 to September 13, 2007. The inspection, carried out under Good Laboratory Practice (GLP) regulations, followed the company's acquisition of Gene Logic Laboratories in late 2006 and a history of previous compliance issues, including a Warning Letter. The inspection identified 12 significant deficiencies across various operational areas. Key issues included the study director's failure to document unforeseen circumstances impacting study integrity and to ensure accurate data recording. The company lacked adequate Standard Operating Procedures for equipment maintenance and calibration, and failed to maintain complete records for these activities. Final study reports often omitted crucial details regarding factors affecting data quality and methodology. Instances of non-adherence to study protocols were noted, along with inadequate archiving of raw data and specimens, particularly for ongoing studies. Furthermore, management did not provide written authorization for significant SOP changes, reagents lacked proper expiration date labeling, and the Quality Assurance Unit demonstrated insufficient independence from study execution personnel. In response, Bridge Global Pharmaceutical Services Inc. management acknowledged the observations and committed to providing a written response within 30 days.

## Related Documents

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Company: https://www.keypedia.com/companies/gene-logic-inc/7b9e6dcf-a764-4435-b4ba-694e2904d871