FDA 483 - good health, inc. - November 29, 2018

This FDA Form 483 documents observations from an inspection of a facility producing beta-lactam drug products. The primary concern is inadequate cleaning of work surfaces, leading to potential cross-contamination.

The facility produces penicillin-containing drug products in the same ISO Class 5 environment as non-penicillin beta-lactam drug products. The cleaning procedure between batches involves only the use of Sterile (b)(4). There are (b)(4) ISO Class 5 hoods located within an ISO Class 7 buffer room used for sterile drug production.

A critical finding is the lack of assurance that the current cleaning process within the hoods prevents cross-contamination between penicillin and non-penicillin beta-lactam drug products. Specifically, on November 9, 2018, production in Hood #E28777 included Ertapenem 500mg/100mL NS, followed by Vancomycin HCl 850mg, and then Penicillin G Potassium, 3MU/D5W 50mL. Between these products, only a cleaning utilizing (b)(4) was performed. The document notes that no cleaning agent is used between products to effectively break down penicillin activity or the beta-lactam ring. This indicates a significant deficiency in the firm's quality system regarding cleaning validation and cross-contamination control for potent and allergenic compounds.