What does FAR stand for?

Field alert reports were not submitted for the stability failures of certain lots of Fluocinonide cream USP 0.

Information obtained during the September inspection and from the company's Field Alert Reports (FAR) indicated a pattern of variability in key quality at tributes of Efudex Topical Cream 5% drug product in the last 2'/z years, the agency noted.

Specifically, FDA stated that a field alert report was filed for ciprofloxacin 500 mg tablets on March 11, 2005, regarding a failure of certain lots to meet hardness at an undisclosed stability time point.

According to the 483, Bruederle hit Baxter for not submitting NDA Field Alert reports within three working days of "learning that stability samples of distributed drug products failed to meet all the established specifications.

Pharmacia was cited for not filing a field alert report after discovering the tainted product.

Lastly, the facility was audited for failure to adequately inspect packaging and labeling equipment prior to its use to assure that all drug products had been removed from previous operations as required; failure to submit NDA Field Alert Reports within three working days of becoming aware of information concerning significant chemical, physical or other change or deterioration in the distributed drug product as required; and, failure of Wyeth's QC unit to review production records to assure that errors had not occurred, and to fully investigate errors that did occur during the manufacturing of drug products.

Thomas pencilled in a citation on the 483 for failure to file a field alert report for acyclovir tablets that were "cracked, softened and/or crumbling.

The agency commented that usage logs for filling/packing equipment did not include an entry for one lot of triamcinolone acetonide cream, which the letter stated was the subject of an NDA field alert report involving tubes of the product mislabeled as gentamicin sulfate.