FDA 483 - McNeil Healthcare, LLC - August 06, 2008

This FDA Form 483 document reports the findings of an inspection conducted at McNeil Healthcare, LLC, a human Over-The-Counter (OTC) drug manufacturer located in Las Piedras, Puerto Rico. The inspection took place over several dates, commencing on July 22, 2008, and concluding on August 6, 2008. The report was issued to Nuria Ramírez Ordóñez, the General Manager of the facility. The FDA Form 483 serves to document observations of objectionable conditions or practices identified by FDA investigators during an inspection. These observations are reported pursuant to Section 704(b) of the Federal Food, Drug, and Cosmetic Act, which mandates reporting of conditions that may indicate a product is adulterated or prepared under insanitary conditions. While the provided excerpt details the administrative information of the inspection, including the company's identity, inspection dates, and the regulatory framework under which the observations are reported, the specific details regarding the main violations or issues observed were not included in this portion of the document. Companies receiving a Form 483 are expected to respond to the FDA, outlining corrective actions to address the identified observations.