The FDA hit drug manufacturer Oakmont Products of Lincoln, Nebraska, with a Form 483 for lacking a quality control unit, among other serious deficiencies.
During a June-July inspection, the agency’s investigators found that the firm had no quality unit to approve or reject components, labeling, drug products or in-process materials. The facility also failed to retain samples of active ingredients for the products it manufactured.
The investigators also flagged the firm’s product testing. For example, it failed to conduct laboratory tests to determine that drug products conformed to the identity and strength of all active ingredients before release and distribution, and didn’t test in-process materials to ensure drug products met specific batch parameters.