Lack of Written Procedures Results in 483 for Drugmaker

May 9, 2014

Alva-Amco Pharmacal’s failure to properly document complaint records and poor recordkeeping earned the OTC drugmaker a Form 483.

During a February inspection of Alva-Amco’s Niles, Ill., plant, investigators reviewed eight complaint records indicating a potential adverse drug reaction. However, six of those records did not include documentation that workers followed up to evaluate the severity of the event and whether it should be reported to the FDA.

The FDA also found that the drugmaker did not retain records that are needed to annually review the quality standards and specifications for drug products.

The drugmaker needed data from its contract manufacturer’s production records on out-of-specification investigations, stability data and rejected or reworked batch records.

However, the company hadn’t received the appropriate data for the past three years, according to the form with five observations.

The FDA also rapped Alva-Amco for not performing a 100 percent examination of package inserts “prior to, during, or immediately following secondary packaging operations of OTC drug products to ensure the correct labeling component is used.”

Alva-Amco said it is addressing the form’s observations and modifying its procedures.

Learn how to prevent 483s from ever happening in the first place, with Creating Effective SOPs: How to Turn a Headache Into a Collaborative Success.