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Quality Compliance Laboratories Announces Successful Completion of FDA Inspection

Published: Wednesday, April 25, 2012
Last Updated: Wednesday, April 25, 2012
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Quality Compliance Laboratories Inc. announces a successful and favorable outcome following the completion of a three-day site inspection from a Food & Drug Administration (FDA) Consumer Safety Officer.

QCL – Quality Compliance Laboratories Inc. announces a successful and favorable outcome following the completion of a three-day site inspection from a Food & Drug Administration (FDA) Consumer Safety Officer.

The audit by FDA resulted in no FDA-483 observations. Once available from the FDA, copies of the Establishment Inspection Report (EIR) will be available to QCL clients upon request. The audit by FDA was initiated as a routine GMP Inspection audit and was hosted at the Markham, Ontario, Canada facility during the 3rd week of January 2012. A wide range of data including–but not limited to; method validation, stability testing and storage, microbiology, raw material and finished product testing, equipment qualification/calibration/maintenance, software validation, investigation, Change Control, and training records, were reviewed during this audit without a single FDA-483 being issued.

This audit was the first FDA inspection of the QCL – Quality Compliance Laboratories Inc. Quality System. In total, the QCL – Quality Compliance Laboratories Inc. have been inspected by two different regulatory authorities, Health Canada and FDA, as well its national and international clients.

QCL – Quality Compliance Laboratories Inc. announces a successful and favorable outcome following the completion of a three-day site inspection from a Food & Drug Administration (FDA) Consumer Safety Officer.

Dr. Mehrdad Barghian, President of QCL – Quality Compliance Laboratories Inc., commented, "Today marks yet another significant milestone in our efforts to ensure highest level of customer service without compromising in quality and safety whilst meeting our client’s tight timelines”. “The result of the FDA and Health Canada audits, are strong statements to our clients regarding our commitment to quality. It should provide our customers with confidence when selecting QCL – Quality Compliance Laboratories Inc. as a GMP laboratory outsourcing partner.”

The audit by FDA resulted in no FDA-483 observations. Once available from the FDA, copies of the Establishment Inspection Report (EIR) will be available to QCL clients upon request. The audit by FDA was initiated as a routine GMP Inspection audit and was hosted at the Markham, Ontario, Canada facility during the 3rd week of January 2012. A wide range of data including–but not limited to; method validation, stability testing and storage, microbiology, raw material and finished product testing, equipment qualification/calibration/maintenance, software validation, investigation, Change Control, and training records, were reviewed during this audit without a single FDA-483 being issued.

This audit was the first FDA inspection of the QCL – Quality Compliance Laboratories Inc. Quality System. In total, the QCL – Quality Compliance Laboratories Inc. have been inspected by two different regulatory authorities, Health Canada and FDA, as well its national and international clients.



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