If a company has no operational quality assurance unit and therefore no basic GMP documents for important manufacturing steps and quality control, the chances of surviving an FDA inspection are pretty slim. Even a reply to the authority's first notice of deficiencies after the inspection (Form 483) hardly makes a difference. Such is the experience of an Austrian drug manufacturer who received a Warning Letter, depicting the following circumstances found by the inspectors when visiting the company:
There was no quality unit with the authority to release components of the medicinal product, containers and closures, in-process materials, packaging materials, labels or the finished drug product. Due to this, there were no basicdocuments such as written procedures for process validation, cleaning validation, packaging and labelling, line clearance, sampling, change control, handling of deviations, OOS studies, etc.
There were no master records for the production and control of products, so that a consistent batch quality could not be guaranteed.
The testing of batches for conformity with the specifications in a quality control laboratory was not performed. They were released without being tested for identity and strength. This also applies to the individual components of the finished products. The suppliers' analysis certificates were accepted without question.
An Import Alert for the manufacturer's products has been in place since October, 2017.