12-15 October 2021
Why the company's answers to the deficiencies were reported insufficient
On 13 May 2020, the FDA issued a Warning Letter to the Korean company Samchundang Pharm Co, Ltd. following an inspection conducted in October 2019. In addition to the topics of "test methods", in particular the sterility test, and employee qualification, this Warning Letter focused on deficiencies in microbiological environmental monitoring. FDA Warning Letters always refer to corresponding chapters of 21 CFR Part 211.
"Your firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas (21 CFR 211.42(c)(10)(iv))
In response to the deficiencies, the company stated that it was revising its microbial identification procedures to identify all "Grade A" and "Grade B" isolates. The grouping of isolates should be refined based on area, operational status, area classification, sampling and morphology.
The FDA considered the answers to be insufficient. In particular, a typical observation in FDA Warning Letters, a retrospective evaluation of the deficiencies found on the quality of products already released, was missing. For ancillary cleanrooms beyond the aseptic core area, the FDA lacked requirements for the identification of microorganisms at species or, if applicable, genus level. These identified microorganisms would also have to be entered into a database.
In response to this Warning Letter, the FDA expects a comprehensive, independent and retrospective review of personnel and environmental monitoring data since 2018, which should include the evaluation and corrective and preventive actions (CAPA) for the monitoring program (including personnel monitoring) to ensure that CAPA measures support robust aseptic filling environment monitoring. The assessment and CAPA measures, including any recommendations from an independent review, should include a justification of sampling locations, sampling frequency, alarm and action limits, adequacy of sampling techniques and trending programme.