As identified in a recently posted FDA warning letter during the inspection, the FDA investigator requested the firm to provide all deviations from environmental monitoring limits. The firm reported that they had no results outside limits for over a year prior to the inspection date…
However, during the inspection the FDA investigator found containers storing environmental and personnel monitoring microbiological samples, dated August 30 and 31, 2017. Numerous samples lacked basic documentation, including missing colony-forming unit (CFU) counts and the identity of the person who collected the sample. At the request of the FDA investigator, your firm enumerated CFU for these plates. While several plates exhibited counts outside of action limits, your firm had not initiated investigations. As an example, a sample taken for [redacted] lot [redacted] yielded an extremely high count of 140 CFUs in your ISO 5 area. The action limit for this critical area is < [redacted] CFU.
As stated in the warning letter – this reported level of environmental control [no issues identified for over a year] is dubious, in that during the current FDA inspection, several environmental monitoring samples were found to have significant growth, and these results had not been enumerated and recorded.
This led the FDA to make the following comment “our failure to accurately account for numerous environmental monitoring plates, enumerate the results, and fully investigate the systemic flaws that led to the unreported data raises questions regarding the integrity of data generated by your firm.”
Additionally in the second observation, the FDA identified that the firms microbiology technician had not collected the required surface samples September 1 – 6, 2017, additionally the firms management acknowledged that deficient environmental monitoring on these production [redacted] and been occurring for approximately 1-2 years.
Ultimately FDA concluded the firm’s quality unit was not able to fully exercise its authority and/or responsibilities and recommeded a data integrity remediation and for the firm to engage a cGMP consultant.
Often we think of Data Integrity (FDA Guidance on DI) in terms of electronic records, audit trails, and data manipulation. FDA briefing on Data Integrity. However Data Integrity is applicable to any data supporting GMPs with a requirement the data are complete, consistent, and accurate. Have a question on Data Integrity? Contact Kevin Marcial or use our Contact Us webpage and we will be happy to respond.
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