Procedures 0317-SOP-QC-00193 “Sampling and Testing procedure of *** and 0317-SOP- C-00118 “Quality monitoring of *** System” were not followed for collecting *** samples. Scheduled samples for specified sample points were not collected. However, analytical records were made to document the samples were collected and used for testing, even though QC microbiology personnel confirmed samples were not collected.

From April 4, 2024-April 13, 2024, there were *** personnel that participated in *** sampling. Each individual on one or more occasion during this time period participated in collecting or documenting *** samples that were not collected from the specified sampling point. For example:

(a) On April 12, 2024, an employee collected *** extra bioburden *** samples from point ***. These samples were represented as points **** which were not sampled. The documented samples for points *** were reported to have all been collected from use point ***

There were *** samples for Bacterial Endotoxin Testing (BET) documented to be collected from *** different points on April 12, 2024. *** of these were collected from a single point, *** The other *** samples were poured into the BET test tubes in the microbiology laboratory with excess sample collected from *** so they could be submitted for testing.

The employee that collected the samples was a fixed term employee not qualified to collect *** samples, enter the production area, or make GMP records. The signed sampling records indicated a second employee had been the sampler, even though that employee confirmed that they had not collected any samples and had instructed the fixed term employee to collect the samples without sampling from each point. These analytical records contained sampling start and end times that did not correlate to actual activities. The sampler in the records was aware the samples they signed for were not collected from the actual locations and identified this was a practice that had been occurring on occasion for the past four months.

(b) On April 6, 2024, an employee collected extra samples from *** sample point *** and represented these as other points that were scheduled for sampling, but not actually sampled, including ***. Additionally, no sample was collected from ***.

The employee that collected the samples was still under qualification and had been directed by a qualified analyst to sample this way to avoid more difficult to sample points. The qualified analyst filled out the analytical records as the sampler, aware that they had not collected samples and the samples were not from the documented location. The qualified analyst confirmed failing to sample from specified locations was not an isolated incident.

On the same day, the analyst under qualification was documented to have collected separate samples for the purpose of analyst qualification from ***. The samples were not observed to be collected. A qualified analyst signed the qualification documentation documenting they had witnessed the sampling for the purpose of analyst qualification.

(c) On April 4, 2024, samples were not observed to be collected from ***. The analyst responsible for sampling stated samples were taken from *** instead, because it is an easier point to access. The analyst acknowledged creating records for *** samples that were not collected and confirmed this was not an isolated incident.

(d) On April 5, 2024, samples were not observed to be collected from ***. The analyst responsible for making the analytical records stated the samples were collected from a different room. The analyst acknowledged creating records for *** samples that were not collected and confirmed this was not an isolated incident.

During interviews with employees responsible for *** sampling on April 15-16, 2024, employees provided inaccurate statements or refused to answer questions.