Inspection issues and deficiencies at contract manufacturers for Adma Biologics Inc.'s primary immunodeficiency treatment RI-002 drew an FDA complete response letter for the company's biologics license application, sending Adma shares (NASDAQ:ADMA) down 17.3 percent to close at $6.49 on Monday.

Neither safety nor efficacy concerns were expressed in the letter, nor did the agency request any additional clinical studies be conducted, Adma's President and CEO Adam Grossman told BioWorld Today. "All of that is solid and sound," he said.

Instead, the agency focused on outstanding inspection issues and deficiencies at Adma's third-party contract manufacturers, including its contract drug substance and product manufacturer, Dreieich, Germany-based Biotest AG, its contract fill and finisher and compliance issues with a third-party contract testing laboratory. The agency also requested documentation of corrections for a number of those issues.

"The good thing that folks can glean is that these are not overarching safety concerns at these facilities," said Grossman, noting that all the contractors were still producing and releasing products. "The majority of the deficiencies have to do with documentation, failure to follow certain SOPs and failure to follow certain rules under the CFR for good manufacturing practices," he said.

Adma execs said all of the identified issues are addressable and can likely be remediated in relatively short order. "Unfortunately, the way the rules work with FDA, as I understand them, is that it's much easier for the agency to take action against a new application than against a product that is already on the market," he added.

It remained unclear at this early point whether the FDA would require a class 1 or class 2 resubmission of Adma's BLA for RI-002, meaning a two-month or a six-month review from time of submission, respectively. But Grossman said he doesn't expect Adma to have to pay any additional PDUFA fees.

Since any new applications presented to the FDA for drugs manufactured in the plants Adma employs could potentially have the same issues as the company and be similarly delayed, Grossman also suggested that there might be an opportunity for alliance with other customers that could give Adma additional influence in working with the vendors to rectify the issues.

The CRL did not cite any concerns with the intravenous immunoglobulin's clinical safety and efficacy, nor has the FDA requested any additional clinical studies be conducted. Despite the setback, Adma said that it is continuing to build its commercial organization and infrastructure "in preparation for the earliest possible launch of our product."

The Ramsey, NJ-based company raised $14.1 million in gross proceeds through an underwritten public offering that closed in May. It intends to use the proceeds from the offering for the procurement of commercial inventory and to build out of a commercial organization and staffing infrastructure relating to its anticipated launch of RI-002.