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FDA issued a warning letter to the Worthing, UK facility for cross contamination and microbial contamination cGMP violations.
FDA announced that it issued a warning letter on June 30, 2016 for cGMP violations to a SmithKline Beecham Limited, Clarendon Road, Worthing, UK, facility. The warning letter follows observations seen during a July 2015 FDA inspection of the facility.
During the FDA inspection, investigators found inadequate controls for cross contamination. Penicillin was found in non-penicillin manufacturing areas a total of 187 times from 2012 to July 7, 2015. The warning letter states that no safe level of penicillin contamination has been determined and contamination of non-beta-lactam drugs with beta-lactam drugs presents significant risk to patients. The company intends to revalidate its penicillin decontamination method; however, FDA stated in the letter that the company’s “response is inadequate because it lacks a comprehensive reassessment of the extent of contamination throughout your facility, a gap analysis of previous decontamination efforts, and a copy of your new decontamination plan.”
FDA also stated that the company’s method validation for penicillin detection and cleaning is inadequate. The agency recommended that the company commit to either dedicating the facility to penicillin only or fully decontaminate the facility, including a comprehensive decontamination plan.
SmithKline Beecham Limited also failed to investigate critical deviations and implement correct and preventive actions, according to FDA. The company, for example, failed to establish the root cause of Burkholderia cepacia contamination in water system loops. Also, a batch of API had bacterial counts exceeding specifications. Sphingomonas paucimobilis was found in a batch of product, but the product was released because it passed microbial count testing. “In your response, you attributed the high bioburden root cause to an extended (b)(4) hold time. Your response is inadequate. Your firm has no established maximum (b)(4) hold time. You failed to include any supporting data to correlate your (b)(4) holding times with increased API bioburden. You did not extend your investigation into the (b)(4) other (b)(4) with similar or longer (b)(4) hold times,” FDA said in the warning letter.
FDA has requested that the company complete corrective actions within 15 working days or the agency may withhold new application or supplement approvals or refuse admission of products manufactured at the Worthing facility into the United States.