Warning Letter due to Serious Deficiencies in Quality Control

In August last year, FDA inspectors visited a Korean pharmaceutical facility. During their tour and after reviewing a number of documents, they found that the quality control department had completely ignored the basic GMP standards. After reviewing the comments on the individual complaints, the authority found them to be totally inadequate and issued a Warning Letter to Soleo, which was published on 13 December 2018.
The GMP violations described in detail in this Warning Letter are interesting in that they reflect the basic expectations of FDA investigators when inspecting the quality control area of a GMP-binding establishment.

The following deficiencies are listed in the Warning Letter:

Missing verification of identity of product components (21 CFR 211.84(d)(1) & (2))

A testing of incoming APIs and excipients was not carried out. Instead, those responsible for quality control relied on the suppliers' certificates without checking their analytical values and the corresponding analytical methods for reliability. There is no detailed procedure in place for such testing. 

Analytical testing methods not validated (21 CFR 211.165(e))

There was no documentation available for the validation of the assay used for the determination of the API content in the final product. Validation parameters such as precision, accuracy, repeatability, etc. have never been determined.

No written procedure for the performance of In-process controls (21 CFR 211.100(a))

The manufacturing process proved to be "out of control" because the corresponding controls were lacking. The company was unable to prove that the process provided a product of consistent quality. There was also no evidence of qualification of the production equipment.

No programme for stability testing  (21 CFR 211.166(a))

Quality Control could not provide stability data from which the expiry date is derived. There was no evidence that the chemical properties of the components of the product did not affect its quality within the lifetime.

These deficiencies in the area of quality control may also be explained by the fact that Soleo's managers were not aware that their product, a shampoo for treating hair loss, was a medicinal product subject to authorisation under Chapter 201(p) of the Food, Drug and Cosmetic Act (FD&C Act), if the declaration on the label (as well as on the website) indicates that the use of the product is associated with a cure, treatment or prevention and affects the function or structure of a body part (pursuant to 201(g)(1)(B) of the FD&C Act (21 U.S.C. 321(g)(1)(B) and 201(g)(1)(C) of the FD&C Act (21 U.S.C. 321(g)(1)(C)).

Soleo's products were placed on Import Alert on November 26, 2018.

To find out more, please see the FDA's Warning Letter to Soleo.