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On 28-Jan-2026, we observed potential for growth of microbial contaminants due to the presence of bird droppings and layers of dust particles inside the (b)(4) HEPA filter (b)(4) ID: (b)(4). We also observed dust materials and potential microbial growth inside the (b)(4) (b)(4) filter (b)(4) HEPA filter (b)(4) of this (b)(4).

2026年1月28日，我們看到由于xx 高效過濾器內(nèi)部有一層鳥糞和灰塵，存在微生物污染物滋生的潛在風(fēng)險(xiǎn)。

On 29-Jan-2026, your Microbiologists collected swab samples for microbial tests from the (b)(4) section of (b)(4) HEPA filter (b)(4) (b)(4) (b)(4) (b)(4) (b)(4) testing revealed TNTC (Too Numerous To Count) colonies. There is a potential for microorganisms, fungal, yeast and mold grown inside the (b)(4) HEPA filter (b)(4) to get carried with the (b)(4) through the (b)(4) Duct into the (b)(4) and potentially contaminate the drug products.

2026年1月29日，貴公司微生物人員從xx高效過濾器采集了微生物擦拭樣品，檢測顯示微生物結(jié)果TNTC（無法計(jì)數(shù)）。xx 高效過濾器上的微生物、真菌、酵母和霉菌隨(b)(4)存在通過(b)(4)管道進(jìn)入(b)(4)并可能污染藥品的潛在風(fēng)險(xiǎn)。

The details of the microbial tests result are as follows:

微生物檢測結(jié)果的詳細(xì)信息如下：

表格說明：

需氧菌總數(shù)（TAMC）：無法計(jì)數(shù)（TNTC）

酵母菌和霉菌總數(shù)（TYMC）：無法計(jì)數(shù)（TNTC）

銅綠假單胞菌：檢出菌落生長

金黃色葡萄球菌：檢出白色、黃色菌落

沙門氏菌：在 (b)(4) 培養(yǎng)基平板上檢出帶黃色暈圈的粉色菌落

大腸埃希菌：檢出白色粉色黏液狀菌落

Your Preventative Maintenance (PM) is deficient for the following reasons:

貴司的預(yù)防性維護(hù)體系存在缺陷，原因如下：

Your procedure SOP No.: FU7-EN-MNP-007, Titled: "PREVENTATIVE MAINTENANCE PROGRAMME", Version: 15.0, Effective date: 24-Sep-2025 has no mention of Quality Unit responsibilities on the physical verification of the condition of (b)(4) Duct, (b)(4) HEPA filters and overall conditions of (b)(4) of (b)(4), during periodic preventative maintenance. Therefore, your Quality Unit failed to evaluate conditions of these areas of (b)(4) of (b)(4) and your Engineering unit simply focused on following the timelines for the replacement of (b)(4) HEPA filters without recognizing the excess (b)(4) materials present inside the (b)(4) Duct and the surrounding areas of (b)(4) HEPA filter inside the (b)(4). As a result, there were no investigation logged to determine the impact and risk of potential products cross-contamination.

貴公司的"預(yù)防性維護(hù)程序"SOP，未提及質(zhì)量部門在定期預(yù)防性維護(hù)期間對xx管道、xx高效過濾器以及xx整體狀況進(jìn)行實(shí)物檢查的職責(zé)。因此，貴公司質(zhì)量部門未能評估這些xx區(qū)域的狀況，工程部門僅專注于按照時(shí)間表更換xx高效過濾器，而未識別xx管道內(nèi)部以及xx 高效過濾器周圍區(qū)域存在的大量xx物料。結(jié)果，未記錄調(diào)查以確定潛在產(chǎn)品交叉污染的影響和風(fēng)險(xiǎn)。