At present, Form 438 seems to be ineffective in assuring that companies to comply with the rules and regulations set by the FDA. For both cases that are stated above, inexperienced companies are companies that may be too large to keep organized, a separate third party regulator may be the proper solution. Often times a company’s own regulation department can be biased, or inexperienced, so instead of making mistakes at the beginning the FDA can require companies to have other people set up the quality assurance of their products. These people will be people who work for the FDA and can help the company put a strong system in place. This will allow companies to get familiar with the standards that are required by the FDA. The employees should also be trained on how to respond to a Form 438 and how to address each of the observations listed on it. The goal of the FDA is to promote compliance so it is important for companies to believe that the FDA is there to help them, not to punish them. However, harsher penalties should be put in place so as to deter companies from trying to get away with noncompliance.