Advocacy
The 483 you can read, and the reply you usually cannot
FDA’s Office of Inspections and Investigations posts selected inspection records in a public reading room: Form 483 observations from U.S. and foreign plants, and some untitled letters. That is often the first public paper, months before a warning letter, and sometimes the only paper if no letter follows.
A 483 is a list of what the investigator saw. It is not a final agency determination. The reading-room page is explicit about the next document: company responses to 483s and warning letters “are generally not posted in this Reading Room unless they have been separately released through a FOIA request or proactive disclosure.” What an advocate can document from the open shelf is the observation. What the firm said back is, unless someone FOIAs it, not on that shelf.
The table is searchable. Recent rows include 483s on sterile-drug producers, outsourcing facilities, and VA medical-center pharmacies. That is the practical limit: you can read the government’s inspection notes when OII chooses to post them. You cannot, from this room alone, read the argument the firm mailed in.
fda.gov — OII FOIA Electronic Reading Room
These notes paraphrase a public government record. They are not legal advice.