Hill Dermaceuticals Gets 483 for Several GMP Issues

The FDA has given Hill Dermaceuticals a Form 483 after an inspection revealed several GMP deviations, such as failure to perform adequate and thorough investigations and to propose adequate corrective actions.

The company did not always complete documentation for deviation investigations, according to a Sept. 10 form. Hill’s quality assurance department further failed to evaluate and challenge or approve all out-of-specification (OOS) investigation reports.

The company is on schedule to have its products fully remediated by April and its equipment was validated last year, Neil Di Spirito, legal counsel for Hill, said.
Drug GMP Report