The United States Food and Drug Administration (FDA) UU has released a highly drafted form 483, sent last month to Glenmark Pharmaceuticals manufacturing facilities in Solan, India on Tuesday.
One of the seven observations on Form 483, first announced by the company on Nov. 28, noted that FDA inspectors found at least 13 quality documents "crushed into the teeth and internal moving parts of the crusher ". "
The FDA stated that the quality documents were not in the logbook as required by one of the site's standard operating procedures.
Further comments focused on the fact that the site did not thoroughly investigate unexplained lot spreads and failures, deficiencies in complaint files and lack of written procedures for production and process controls.
In one case, Form 483 indicates that the company attributed a batch error to the sample preparation error "by providing photographs of sample vials indicating alleged preparations of abnormal samples". The photographs included in the survey did not include stamps. of date ... The authenticity of the supporting photographs could not be verified by the investigators of the FDA. "
Glenmark stated that the manufacturing unit that received Form 483 contributes about 10% of the company's sales to the United States. UU And that the company "is in the process of providing a complete response to the observations."
