After discussing the difference between an FDA Form 483 and an FDA Warning Letter, it may perhaps be worthwhile to take a closer look at some of the most recent actions that have occurred (including new FDA 483 Forms and Warning Letters). Although perhaps a couple of months have already passed, but March of 2019 makes a great example for looking at exactly how aggressively the FDA is proceeding with their efforts on these facility inspections.
How Many FDA 483’s and Warning Letters Were Issued in March of this Year?
In just the month of March, the FDA issued a total of eleven (11) 483 Forms (including FMD 145 letters) and one (1) Warning Letter. Let’s take a closer look at some of these examples and take a closer look at what the FDA observers and inspectors are actually concentrating on when they visit a facility.
Please take note that you should probably download each of the 483 forms discussed in the examples below and take a closer look when time permits (we’ve included a link for each individual 483 form for downloading the actual PDF posted on the FDA’s website). In both of the first two examples that we’ll take a look at there are nine (9) observations total, but a closer look reveals that each observation may have numerous additional points “attached” to it that also need to be addressed by the compounding facility.
- QuVa Pharma Inc. in Temple, Texas is known for providing 503B outsourcing services and concentrates on compounded drug formulations and medications for obstetrics, OR, anesthesia, general medicine, cardiovascular, ER, and pain management. QuVa received a 483 Form after an observational inspection on March 14th of 2019. Click here to download a full copy from the FDA that you can review, but the operation was listed with a total of nine (9) “observations” on the 483 Form. The majority were based on a lack of procedural documentation and the lack of written Policies and Procedures specific to how they perform their compounding services.
Two that summed up the observations are definitely worth noting here:
– “Written procedures are lacking which describe in sufficient detail the receipt, identification, approval, and rejection of components”.
– “There are no established written methods of cleaning or methods of processing to remove pyrogenic properties”.
- ACRx Specialty Pharmacy located in Las Vegas, Nevada performs both sterile and non-sterile compounding of products, specializing in Women’s Health products, Ophthalmology, Thyroid Dysfunction and Weight Loss. ACRx retrieved a 483 Form on 3/20/2019. The 483 listed a total of nine (9) “observations”, and as in the QuVa example above, the majority were based on a lack of procedural documentation and the lack of written Policies and Procedures specific to how they actually perform their compounding services. Click here to download the entire 483 Form that they received.
Just to point out quickly again what the FDA was concentrating on while observing the operation of the compounding facility, let’s use the exact verbiage from the form:
– “Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established”.
– “Written procedures for cleaning and maintenance fail to include maintenance and cleaning schedules, description in sufficient detail of methods, equipment and materials used, description in sufficient detail of the methods of disassembling and reassembling equipment as necessary to assure proper cleaning and maintenance, instructions for protection of clean equipment from contamination prior to use and parameters relevant to the operation”.
- Customceutical Compounding located in Phoenix, Arizona received a 483 Form on March 8th of 2019 (Click here to download the entire 483 Form that they received). Known primarily for the compounding of Injectable Medications, Ophthlamics (eye drops & ointments), Inhalation Solutions and Intrathecals, they had a total of five (5) documented observations noted. Again, the observations centered around the fact that the facility’s “procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not adequate”.
- Front Door Pharmacy (DBA Pure Pharmaceuticals) in Houston, Texas received their 483 Form on March 20th this year. (Once again, click here to download the entire 483 Form that they received as a PDF from the FDA website.) Front Door Pharmacy had a “whopping” eleven (11) documented observations that included a lack of documented policies and procedures as noted in the examples discussed above. However, the specificity of some of the observations that were noted make a great example of the level of actual “scrutiny” that the FDA is exhibiting:
– Personnel engaged in aseptic processing were observed with exposed skin.
– Personnel touched equipment or other surfaces located outside of the ISO 5 classified aseptic processing area with gloved hands and then engaged in aseptic processing without changing or sanitizing gloves.
– Equipment and materials or supplies were no disinfected prior to entering the aseptic processing area.
How Do You Prepare For the Inevitable FDA Inspection?
Once again, these are just a few examples of the detailed level of observation and documentation that the FDA is exhibiting. An actual discussion of each noted observation for each 483 Form would take several hours, but we recommend that you actually take a very close look at at least one of these forms that were issued to get an accurate idea of the depth of the the detail involved. Keep in mind that the FDA will thoroughly review the facility’s response and revisit to see whether or not the operation is doing their utmost to be in compliance. Also consider that if the response is found to be lacking, then the next step is the “dreaded” Warning Letter!
The answer is to take action now and be prepared! In other words, take a look now and don’t wait for the inevitable inspection that is certain to come! The FDA strongly recommends that you undertake a comprehensive assessment of your facility’s current operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems. As the FDA actually states: “A third-party consultant with relevant sterile drug production expertise should assist you in conducting this comprehensive evaluation”. The FDA also points out very clearly that “It is YOUR responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations”.
Which Third-Party Pharmacy Consulting Firm Can Help Me?
Healthcare Consultants has been known as a national leader in pharmacy consulting for over 30+ years now. Since 1989, our network of experienced pharmacy consultants and in-house specialists have provided expert guidance across all sectors of the pharmacy industry. We work with pharmacies of every size – from the corner drug store to national corporations and organizations – with only one goal in mind: to improve your pharmacy’s business operations.
One of the services that HCC specializes in is the development and customization of both 503A and 503B Policies and Procedures. We have nationally renowned in-house experts and consultants with proven “track records” and successful results in responding to both FDA 483 Forms and Warning Letters.
We urge you to contact us today to see how our Pharmacy Consulting services can fit your needs and help you improve your business now, plus be ready for the future. With a full-time staff of experienced in-house Pharmacy Consulting specialists, HCC can answer any questions that you may have in all Pharmacy settings. Contact us online now or call us today at 800-642-1652 for a free consultation.