3. Your firm failed to maintain buildings used in the manufacture, processing, packing, or holding of drug products in a good state of repair (21 CFR 211.58).

3. 贵公司未能将用于药品生产、加工、包装或储存的建筑物保持在良好的维修状态（《联邦法规法典》第 21 篇第 211.58 条） 。

Our investigators observed water damage and mold-like substance in the entrance way of the R&D Center Building. Additionally, the ceiling of the (b)(4)-floor warehouse in the R&D Center Building was actively leaking during the inspection, and our investigators observed that you attached plastic sheeting to the ceiling in attempts to contain the leak. Your R&D Center Building is used in the manufacture and storage of your drug product, including the (b)(4)-floor warehouse for storing packaging components for your drug product.

我们的调查人员在研发中心大楼的入口处发现了因水造成的损坏以及类似霉菌的物质。此外，在检查期间，研发中心大楼(b)(4)层仓库的天花板正在漏水，我们的调查人员看到你们在天花板上覆盖了塑料布，试图控制漏水情况。你们的研发中心大楼用于药品的生产和储存，包括(b)(4)层仓库，该仓库用于储存药品的包装部件。

It is essential that your facility is in a good state of repair and sanitary conditions are maintained to protect drug products from potential routes of contamination.

你们的设施处于良好的维修状态并保持卫生条件至关重要，这样才能保护药品免受潜在的污染途径影响。