FDA Compliance
25 January 2011
Broughton Laboratories are delighted to announce that their recent FDA regulatory inspection was deemed a major success. On July 27, 2010, the FDA gave their verdict: Broughton Laboratories site complies with good manufacturing practises (GMP) and no 483‘s were issued.
Carried out in the summer, the two day inspection involved the heavy scrutiny of protocols, specifications, calculations, equipment records, workbooks and training records with very positive conclusions made by the visiting inspectors.
The lead FDA Investigator, considered an expert in GMP compliance and the second Investigator, an analytical chemist who focused upon data integrity, was particularly interested in the thoroughness of the company’s current research into dissolution calibration.
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