Because of the Corona crisis, the fact that an auditor has to visit a site currently presents a potential risk to all persons involved or might simply not be possible because of travel bans. What are the options now?
Shredding Key Documents and Leading Investigators to Incorrect Rooms - An unusual FDA Warning Letter
FDA Warning letters often refer to insufficient documentation, missing validations, inadequate training, employees not following procedures, or similar cases. But shredding documents and leading investigators to incorrect rooms during an inspection is rather unusual.
Foreign Particles in Oral Dosage Forms can also Cause Warning Letter
A US-American medical manufacturer has received a Warning Letter from the FDA due to foreign particles in a solution for oral application and especially regarding the handling of this incident. Besides, further deficiencies were observed during the inspection, such as errors in the evaluation of HPLC data and data integrity in the laboratory in general.
FDA Warning Letter to Indian Manufacturer for Inadequate Testing of Incoming APIs
In a Warning Letter to an Indian manufacturer, the FDA notes that the firm lacked adequate testing for incoming API and relied on the suppliers' certificates of analyses (COA) without establishing the reliability of the suppliers' analyses through appropriate validation.
The European Commission has published an aide memoire for Good Distribution Practices (GDP) inspection of wholesalers’ compliance with Commission Delegated Regulation (EU) 2016/161 for safety features.
Deficiencies in Maintenance, OOS and Data Integrity lead to Warning Letter
A pharmaceutical manufacturer in India received a Warning Letter from the US-American FDA in December due to deficiencies in the areas of maintenance/cleanliness, OOS and data integrity. Read more here.
Warning Letter for US Manufacturer: Issues in the Water System
A US-American pharmaceutical manufacturer received a Warning Letter from the FDA in November 2019 due to microbial issues in the water system, deficiencies in qualification/validation and insufficient stability data. Read more here.
Stability Testing Program as a Common Problem in recent FDA Warning Letters
Stability testing of drug products is required by 21 CFR 211.166 of the cGMP guidelines. There has been an increase in GMP violations related to stability testing. A few days ago, a German company received an FDA Warning Letter in which, among others, the stability program was criticized.