By Grant Merrill
Whether you are an emerging startup, an outsourcing facility, or an established pharma organization, maintaining FDA compliance is essential to your business operations. Downtime of any sort could derail your business and potentially harm patients. Making sure that your cleanroom facility remains safe for your workers – and that the therapeutics they produce remain safe for patients - is an important part of the compliance process.
Form 483 is the tool FDA Office of Regulatory Affairs (ORA) inspectors use to report compliance issues. Receiving a Form 483 regarding your cleanroom facility means that something has gone wrong—either a worker was witnessed doing something unsafe or the facility itself was in disrepair.
We review common Form 483 violations for cleanrooms and how our modular systems can ease your compliance concerns.