FDA Warning Letter to pharmaceutical manufacturer in Taiwan who owns ISO Certificates

Asia has been in the centre of attention when it comes to GMP non-compliance. This time the company KO DA Pharmaceuticals Co has been inspected by FDA and received a Warning Letter. The company is located in No. 20-1, Gongye 3rd Rd., Pingzhen Dist., Taoyuan City, Taiwan 324.

Normally an FDA Warning Letter contains a long list of deviations detected during the inspection. But here even fundamental GMP requirements are not in place. The FDA lists:

1.    Your firm’s quality control unit failed to approve or reject all procedures or specifications impacting on the identity, strength, quality, and purity of the drug product (21 CFR 211.22(c)).

2.    Your firm failed to establish adequate written procedures for production and process controls, including validation protocols and reports, designed to assure that the drug products your firm manufactures have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).

3.    Your firm failed to withhold from use each lot of components, drug product containers, and closures until the lot had been sampled, tested, or examined, as appropriate, and released for use by the quality control unit (21 CFR 211.84(a)).  

4.    Your firm failed to establish and follow written procedures for the preparation of master production and control records designed to assure uniformity from batch to batch (21 CFR 211.186(a)).

This is also why the company decided to stop manufacturing and distributing the products to the US that are listed in the Warning Letter. However, on the web the company promotes its own quality system with a number of certifiicates. According to these certifcates the company's quality system meets the expectation of ISO 9001:2008 (certified by SGS and valid until May 2016) as well as ISO/IEC 17025 (accreditation by TAF and valid until August 2016). This again raises concerns about the relevance of ISO certifications and accreditations. In Europe the German certification body TÜV also came under pressure some years ago (at this time a Medical Device was concerned). The French company PIP was involved in serious quality violations and fraud. The violations were detected by the French authority AFSSAPS. However, the company PIP had a valid certificate issued by TÜV although the company didn't even meet basic standards with regard to the quality system. Currently the European Commission is in a process to revise the regulation for Medical Devices (which includes the certification process). The PIP scandal was the main driver for many of the changes.

Source: FDA Warning Letter to Ko Da Pharmaceuticals