12/13 October 2021
During an inspection performed from September 1 to 11, 2017 at the Taiwanese company Taiwan Biotech Co., Ltd, the inspector criticised the company's microbiological monitoring programme. The company's response to the deviations was insufficient. On 31 May 2018, a Warning Letter was thus issued to the company.
FDA Warning Letters always refer the observed deficiencies to the corresponding chapters laid down in 21 CFR Part 211; in that case, to 21 CFR 211.42(c)(10)(iv) "Your firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas".
The violations observed focussed on two areas:
Environmental and Personnel Monitoring Alert Investigations
Here, there was a data integrity problem. The following situation led to this statement. During the inspection, the inspector found containers with environmental and personnel monitoring samples dated from the previous week. Those samples lacked adequate documentation. Neither the plates were enumerated nor could the person who collected the sample be identified. At the inspector's request, the plates were enumerated. Although many of these plates exhibited CFU values outside of the action limit, the company didn't initiate any investigation.
Thereupon, the inspector asked for an overview of all deviations from environmental monitoring. According to the company, there had been no deviations outside limits the year before. Based on the deviations observed during the inspection, the statement sounded more than dubious.
Insufficient surface monitoring
The inspector noticed that the responsible microbiological technician hadn't collected any surface samples for 6 days. Thereupon, the management confirmed that insufficient environmental monitoring on this production area had been occurring for already 1-2 years.
The company's response to create a respective SOP and to hire more personnel was inadequate for the FDA. Neither a SOP nor plans to update the environmental monitoring programme were provided. Besides, there was no reaction to the unaccounted samples identified by the inspector. No information was provided whether they had been enumerated and whether investigations or risk assessments had been initiated for the results outside limits.
What does the FDA expect in response to this Warning Letter: