483 Observations and Warnings - What’s The Difference? | Newsletter | Issue 03 | 2020

The U.S. Food and Drug Administration (FDA) is responsible for protecting public health by ensuring the safety, efficacy, and security of pharmaceuticals, biologics, and much more. It is one of the leading regulatory and compliance agencies that a compounding pharmacy will work alongside while developing products.

The FDA is responsible for routine inspections, which many manufacturers know all too well! But, three little numbers - 483 - can come from the inspections, and they mean serious business. But there are two different types of terms associated with these numbers: "Observations" and "Warning Letters." Today, we'll look at the difference between the two, what to do if your pharmacy receives one, and how MediZap can help you stay compliant.

483 Observations - Just Taking A Look

An FDA 483 observation is a document that will highlight any potential regulatory violations found during a routine inspection. The violations can vary widely - from facility and equipment, to processes and controls, and even to employment practices and records. Observations can be expensive to fix depending on the severity. The most common causes for a 483 observation are procedures not correctly or fully followed, inadequate systems, and the absence of written procedures.

If you receive one of these unfortunate observations, make sure to review the document with an inspector from the FDA to understand the concerns and how to rectify them. Make sure to follow up and respond in writing within 15 days. Failure to demonstrate that the problems have been handled can result in something worse...a formal 483 warning letter.

483 Warning Letter - Serious Business

A step further than a 483 observation, a 483 warning letter is a formal notification that identifies serious and business-threatening regulatory violations. More senior FDA officials issue a warning letter after they’ve reviewed your inspector’s report. The most common causes for these warning letters include non-compliant written procedures or failure to follow ANY guidelines, or the inability to prove that regulations have been addressed and followed-up after an observation.

Just like an observation, warning letters require a response within 15 days. However, if the letter’s cause is severe, the FDA may escalate the deadline, and you are obligated to rectify the violations in a warning letter. This is a discernable difference between an observation and a warning. Additionally, warning letters are made public, and competitors may use this against you if they notice it and want to capitalize on it.

The Importance Of Compliance

Staying in compliance is of critical importance for a compounding pharmacy. When you work with MediZap, you can ensure that our innovations in packaging, our trusted partnerships, and our dedication to compliance are rock-solid start to finish.

We’re here for you - we offer support, guidance, and best practices for each customer. Think of us as an extension of your quality control and quality assurance teams. From document management to validation, you will feel confident in your sterile compounding operations working with us. We also leverage direct contact with regulatory agencies like the FDA and have an excellent working relationship with these agencies.

Last but not least, we’re there for your document control needs and are there to help you prepare for your audits and inspections. We know the industry - we prepare consolidated industry information guides and are happy to act as an additional knowledge base for compliance advice so that you can focus on what you do best!

You can count on us when it comes to compliance. Contact us if you have any questions about FDA 483 Observations or Warning Letters, compliance in general, or about our services.

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