Determination of Nonresponsibility because of Failure To Receive FDA Approval

A company protested a determination that it was nonresponsible because of its failure to receive Food and Drug Administration (FDA) approval. The determination was reasonable in spite of the fact that FDA was unable to evaluate the offeror's foreign supplier because negotiations had proceeded for six months and supplies were urgently needed. The burden is on the offeror to obtain approval either before or within reasonable time after submitting its proposal.