What Does the FDA Investigate Anyway?

An FDA inspec­tion is one of the most sig­nif­i­cant inspec­tion rou­tines that com­pa­nies man­u­fac­tur­ing drugs, med­ical devices, and oth­er prod­ucts con­sumed by humans and pets should pre­pare for.

Here we will dis­cuss what the FDA is, the type of inspec­tions it does, who is sub­ject to FDA facil­i­ty inspec­tions, how to pre­pare for one, and how Kaloutas can help along the way. 

What Is the FDA, and What Do They Do?

The Food and Drug Admin­is­tra­tion (FDA) is a fed­er­al agency with­in the Unit­ed States Depart­ment of Health and Human Ser­vices. It has been around for over a cen­tu­ry to pro­mote and pro­tect pub­lic health. 

The FDA ful­fills this mis­sion by ensur­ing the effi­ca­cy, safe­ty, and secu­ri­ty of prod­ucts con­sumed or used by humans and even ani­mals. FDA reg­u­lates drugs, med­ical devices, and bio­log­i­cals. They also over­see the safe­ty of cer­tain food sup­plies, cos­met­ics, and prod­ucts that give off radiation. 

Even prod­ucts for ani­mals, includ­ing live­stock foods, pet foods, and vet­eri­nary drugs and devices, are reg­u­lat­ed by the agency. 

An FDA inspec­tion is a crit­i­cal, care­ful, offi­cial on-site assess­ment of facil­i­ties that man­u­fac­ture, dis­trib­ute, and mar­ket FDA-reg­u­lat­ed prod­ucts to deter­mine their com­pli­ance with the law. The FDA con­ducts inspec­tions to ensure that facil­i­ties meet the agen­cy’s rig­or­ous stan­dards for safe­ty, qual­i­ty, and effectiveness. 

Types of FDA Inspections 

FDA inspec­tions come in four main vari­eties. What are the four types of inspec­tion for the FDA? They are pre-approval inspec­tion, rou­tine inspec­tion, com­pli­ance fol­low-up inspec­tion, and for-cause inspection. 

● Pre-Approval Inspec­tions: The FDA con­ducts this inspec­tion when a facil­i­ty or man­u­fac­tur­er sends an appli­ca­tion to mar­ket a new prod­uct. The goal of the inspec­tion is to ensure the facil­i­ty can man­u­fac­ture qual­i­ty prod­ucts con­sis­tent­ly and that the new prod­uct meets FDA reg­u­la­tions. The FDA also sends a noti­fi­ca­tion before con­duct­ing this inspection. 

● Rou­tine Inspec­tions: Here, the FDA mon­i­tors a facil­i­ty’s man­u­fac­tur­ing process to deter­mine whether it com­plies with qual­i­ty man­u­fac­tur­ing prac­tices. An FDA inspec­tor usu­al­ly noti­fies the facil­i­ty before the rou­tine inspec­tion 2 – 5 busi­ness days in advance. 

● Com­pli­ance Fol­low-Up Inspec­tions: The FDA con­ducts this type of Inspec­tions: The FDA con­ducts this type of inspec­tion to ver­i­fy cor­rec­tive actions tak­en by a facil­i­ty that had pre­vi­ous violations. 

● For-Cause Inspec­tions: This is con­duct­ed when the FDA receives spe­cif­ic com­plaints from con­sumers or employ­ees. Unlike sur­veil­lance and preap­proval inspec­tions, the FDA can con­duct a for-cause inspec­tion with­out noti­fy­ing the facility. 

Kaloutas under­stands the ins and outs of each of these kinds of FDA inspec­tion and offers com­pli­men­ta­ry facil­i­ty walk­throughs to help iden­ti­fy the areas that might be in violation. 

What Does the FDA Inspect? 

When the FDA con­ducts an inspec­tion, the agency assess­es var­i­ous aspects of a busi­ness oper­a­tion, includ­ing but not lim­it­ed to:

● Design Con­trols: The FDA inspec­tor will assess whether a prod­uct design meets its intend­ed purpose. 

● Records: Dur­ing an inspec­tion, the FDA will review all rel­e­vant doc­u­ments and records to ensure com­pli­ance with reg­u­la­to­ry requirements. 

● Process­es and Oper­a­tions: The inspec­tor will eval­u­ate the man­u­fac­tur­ing process­es and oper­a­tions to ensure they meet the agen­cy’s qual­i­ty standards. 

● Man­u­fac­tur­ing Envi­ron­ment: The inspec­tor will assess the man­u­fac­tur­ing envi­ron­ment, includ­ing san­i­ta­tion, in which FDA-reg­u­lat­ed prod­ucts are produced. 

When mak­ing Kaloutas your trust­ed facil­i­ty inspec­tion part­ner, you can rely on our indus­try experts to care­ful­ly eval­u­ate all aspects of your build­ing and oper­a­tion to ensure it remains in com­pli­ance with safe­ty pro­to­cols, deferred main­te­nance, and more. 

What Trig­gers an FDA Inspection? 

If your facil­i­ty is just get­ting start­ed, has a his­to­ry of com­pli­ance prob­lems, or has start­ed man­u­fac­tur­ing new prod­ucts under FDA reg­u­la­tions, you can expect the agency to vis­it your busi­ness for an inspec­tion soon­er or later. 

The FDA also con­ducts rou­tine inspec­tions at least once every five years for domes­tic non-high-risk facil­i­ties, but they do it once every three years for high-risk ones. 

Know­ing this, Kaloutas con­ducts its facil­i­ty inspec­tions with you on a reg­u­lar basis and in a time­ly man­ner, so you are always prepared. 

The FDA inspec­tion begins when an inves­ti­ga­tor arrives at your facil­i­ty, intro­duces them­selves, and presents a ​“Notice of Inspec­tion.” Note that the inspec­tion can hap­pen unan­nounced, depend­ing on the type. The inspec­tor will get to work after the introduction. 

The inspec­tion can last for days or even months, depend­ing on the nature of the inspec­tion, the size of your facil­i­ty, and the com­pli­ca­tions that arise. The FDA inspec­tor will dis­cuss their key find­ings with facil­i­ty man­age­ment upon inspec­tion com­ple­tion. If your facil­i­ty fails, the inspec­tor will also issue Form 483, which details any vio­la­tions or objec­tion­able find­ings dis­cov­ered dur­ing the inspection. 

How Do I Pre­pare for an FDA inspection? 

Whether your facil­i­ty is get­ting a rou­tine or tar­get­ed inspec­tion, ade­quate plan­ning is nec­es­sary to ensure a suc­cess­ful inspec­tion. That’s where Kaloutas comes in. 

When an inspec­tor arrives at your facil­i­ty, you may pan­ic or feel calm. The lat­ter is only pos­si­ble if you have done enough prepa­ra­tion. If you have nev­er got­ten around to the nec­es­sary prepa­ra­tion, it’s easy to become ner­vous. Fail­ing an inspec­tion can have seri­ous consequences. 

With most types of inspec­tions, the FDA will announce the inspec­tion before­hand. This will give you the lux­u­ry of hav­ing a few days or weeks to pre­pare your facil­i­ty. But if Com­plaints trig­gered the FDA inspec­tion; you may be sur­prised that FDA per­son­nel are already at your door unannounced. 

Don’t wor­ry. Below are some prepa­ra­tion tips to help you (espe­cial­ly if the FDA does­n’t give you time to pre­pare for their arrival), as well as exam­ples of ways we at Kaloutas pre­pare our cus­tomers for FDA and oth­er inspections. 

Cre­ate Clear and Con­cise FDA Inspec­tion Procedures. 

If your facil­i­ty is new, you must devel­op a stan­dard oper­at­ing pro­ce­dure (SOP) for man­ag­ing FDA inspec­tions. When you do, ensure the list of do’s and don’ts is con­cise and easy to under­stand. Then, devel­op an inspec­tion readi­ness team. Check in with them to learn how they have inter­pret­ed the pro­ce­dure and ensure they under­stand their responsibilities. 

Because Kaloutas has so much expe­ri­ence with these inspec­tions, we can help you devel­op effi­cient SOPs for pass­ing inspections. 

Devel­op a Robust Doc­u­men­ta­tion System. 

You’ll need to present rel­e­vant doc­u­ments to an FDA inspec­tor for audit­ing. Ensure your staff doc­u­ments process, pro­ce­dures, and per­son­nel train­ing, and keep the records up to date. Also, imple­ment a robust doc­u­men­ta­tion sys­tem that gives you easy and quick access to all nec­es­sary doc­u­ments and records. This will help move the inspec­tion process along as fast as possible. 

Kaloutas can guide you in prop­er record-keep­ing, too. 

Make a Phys­i­cal Inspec­tion Binder 

An inspec­tion binder is a con­ve­nient way to com­pile and present nec­es­sary infor­ma­tion to inspec­tors. By get­ting every­thing ready, you can avoid mak­ing the inves­ti­ga­tor wait unrea­son­ably long to see cer­tain doc­u­ments. This will pre­vent delays that sug­gest dis­or­ga­ni­za­tion, which might affect the inspec­tion results. 

FDA inspec­tors will assess the con­di­tion of your facil­i­ty and your equip­ment. A pre­ven­tive main­te­nance program. 

Com­pile Prod­uct Com­plaints from Pre­vi­ous Inspections. 

Don’t ignore com­plaints you’ve received from cus­tomers, employ­ees, and oth­er stake­hold­ers. Get the reports ready ahead of time and des­ig­nate some­one who can clear­ly explain the com­plaints and res­o­lu­tion process­es in place. 

Con­duct Inter­nal Audits and Mock Inspections 

The FDA con­ducts rou­tine inspec­tions, so prepa­ra­tion is still crit­i­cal even if you stay com­pli­ant with their reg­u­la­tions. Reg­u­lar­ly per­form­ing inter­nal audits will help your facil­i­ty stay inspec­tion ready. It will allow you to deter­mine areas for improve­ment and gaps in readi­ness. This enables you to imple­ment cor­rec­tive actions before the inspec­tion begins. 

Kaloutas offers com­pli­men­ta­ry facil­i­ty walk­throughs and can help iden­ti­fy the areas that might be in violation. 

Com­pli­ance With FDA Reg­u­la­tions Isn’t Option­al

Fail­ing an FDA inspec­tion has sev­er­al con­se­quences. If you don’t address issues brought to light by the inspec­tor and includ­ed in Form 483, the FDA may take fur­ther reg­u­la­to­ry action. 

The FDA could have the com­pa­ny issue a recall of affect­ed prod­ucts already on the mar­ket. The FDA may work with the Depart­ment of Jus­tice to issue a con­sent decree or an injunc­tion for your facil­i­ty. This is a legal order pro­hibit­ing a facil­i­ty from man­u­fac­tur­ing and dis­trib­ut­ing a prod­uct until they have cor­rect­ed their violations. 

Ignor­ing vio­la­tions may even lead to crim­i­nal pros­e­cu­tion. In the worst-case sce­nario, the FDA can ban a com­pa­ny or indi­vid­ual from work­ing in any capac­i­ty in an industry. 

So, once you receive the find­ings, care­ful­ly review every­thing. Send the FDA your response to the obser­va­tions cit­ed in Form 483 with­in 15 days. Also, devel­op and imple­ment cor­rec­tive action plans. 

An FDA inspec­tion can be over­whelm­ing and incon­ve­nient, but fail­ing the inspec­tion is even worse. So, ensure your facil­i­ty is ready by learn­ing and prepar­ing every­thing accord­ing to FDA inspec­tion guidelines. 

Let Us Help You Ace FDA Com­pli­ance in New Eng­land!

Kaloutas can help ensure cer­tain aspects of your facil­i­ty are inspec­tion ready. In addi­tion to our facil­i­ty inspec­tion offer­ings, we offer var­i­ous ser­vices, includ­ing fire­proof­ing, indus­tri­al floor­ing and clean­ing, con­tain­ment, and more for New Eng­land com­mer­cial and indus­tri­al facilities. 

What­ev­er project you need, our team will ensure com­pli­ance with reg­u­la­tions. Ace every FDA inspec­tion with Kaloutas’ exper­tise and pro­grams. Con­tact us to learn more.