Warning Letter due to Non-Compliance with 3D Rule

A Chinese manufacturer has received a Warning Letter from the US-American FDA due to inadequate equipment design, deficiencies in monitoring and not performed laboratory tests as well as deficiencies in the Batch Record Review.

Even if it is not explicitly mentioned in the Warning Letter, it is to be presumed that the system complained about is the water system. However, the FDA explicitly mentions dead legs as the reason for the complaint and the danger of the development of biofilms. Besides, the FDA criticizes that the slope is not specified on the piping diagrams (note: a sufficient slope is important for residual drainability). Furthermore, the FDA criticizes the maintenance of the system. Corrosion was noticed on valves, pipes, fittings and tanks.

The microbiological monitoring of the system also gave cause for complaint. The total aerobic microbial count (TAMC) over a longer period of time was not examined at all. However, OOS results were received later.

The FDA now expects a plan on how to bring the system to a GMP-compliant level with regard to design, maintenance and monitoring, and also a validation of the system. In addition, the FDA expects a risk assessment for all affected batches that were delivered to the USA.

No quality investigations were carried out during product testing either. As a result, batches had been released for which the required microbiological tests had not been carried out. In this instance, the FDA also expects a risk assessment for batches that have been released for the US-American market. In addition, the manufacturer should provide a list of all chemical and microbiological tests and specifications and also examine all required retained samples.

Another finding concerns the entire quality system and the quality unit itself. The unit is accused of not having sufficient oversight over production. According to the FDA, there are no written procedures on how to perform a Batch Record Review (BRR) or how to check electronic data. In addition, the quality unit had released batches for the market despite deviations in the manufacturing records.

The FDA therefore judges the manufacturer's entire quality system to be inadequate and recommends engaging an external consultant.

Please see the FDA website where you can find the original Warning Letter to Guangzhou Tinci Materials Technology.

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