Microbiological Environmental Monitoring in the Focus of an FDA Warning Letter

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
  • Insufficient surface monitoring

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:

  • Further details on the plates that weren't initially enumerated and particularly on the results. All batches which have been manufactured within the inadequate monitoring programme should be identified. A risk assessment should also be provided of any potentially affected products marketed to the USA.
  • Investigations of deviations from action limits for ISO 5 and other clean areas.
  • A comprehensive and independent assessment with CAPAs for the environmental monitoring and personnel monitoring programmes.
  • An extensive and independent review of the laboratory practices, methods, equipment, and analysts' competencies.
  • A comprehensive identification of all contamination hazards in the aseptic processes, equipment, and facilities. Furthermore, an independent risk assessment is expected that covers, among other things, all human interactions with the ISO 5 area, equipment placement, ergonomics, air quality in the ISO 5 area and surrounding room, etc.

Source: FDA Warning Letter for Taiwan Biotech Co.,Ltd, dated 31.5.2018

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