USFDA findings of 483 and learning from it

 

We learnt about what is 483, its consequences and if not taken seriously then it results into warning letter. We also learnt what is warning letter.

 Let us now learn about what sort of 483’s are being issued in medical device industry in general by just looking at several types of 483s give to many in this medical device field. This will provide us the guidance as what are expected and how do we can avoid such 483 and make our inspection very worthy.

 General trends in form 483 observations:

 

1.       Procedure not written or not fully followed. US FDA system suggests that any activity you are doing must be described in written form of instruction so all follow the same path and do not use multiple option. Since lot of documentation is needed it is observed that job is done in hurry to complete the requirement but that creates this deficiency. Sometimes it is written in such a way that it becomes difficult to follow or short cut is chosen which turns out deficient. Some time even procedure itself is not written.

2.       Poor investigation and CAPA. This happens with many and in repetitive manner so full attention with expert consultant’s help may be sought.

3.       Laboratory controls to evaluate your devices or component are essential and that control includes sound method which are validated and well accepted.

4.       Validation is word which is always found in 483 in one way or other. Though this technique is so sound that if conducted properly it provides so much assurance and confidence that system does not need frequent check. This should be considered as useful tool for assurance for you and your customer and not just mere regulatory requirement. This approach only will solve this issue.

Now if you take 2019 483s,

 All except no. 5, all were found in one way or other. In 7 years, industry progress so well and so also regulatory but such continuance throws a bad image of industry. It may not be necessary that one company got many such repetitive observation, but all available information on website is not taken for learning by many devices manufacturer.

It is recommended that such observations must be studied, and self-check should be done. Awareness, self-inspection to deliberately to look at these observations. Wherever your company feels that it is weak at certain point, expert help of US FDA Consultant may be sought to find proper answer and create back up system through proper procedure, training and implementation and frequent audit to check result and progress.

Certain new observations:

1.Facilities shall include defined areas of sufficient size. This point gain momentum because industry ventured into area where additional different type of area needed for that activity as per cGMP guideline. Either lack of knowledge or hurry of expansion without reviewing cGMP condition in new scenario.

2. Stability testing, though more applicable to drug product but essence is extendable to medical device industry too.

FDA is not mere inspector but supports industry with lot of new guidelines, so such observations are reduced and improvement in new area is done.

 

Apart from above general trend comparison, ten most common FDA 483 observation in medical device field are listed below. (Source: Reasons for FDA 483 observations and warning letter citations in medical device environments)

 

1.Complaint handling procedure are inadequate.

2.CAPA procedure are inadequate.

3.Written medical device reporting procedure are inadequate.

4.CAPA actions are inadequately documented.

5.Process validation procedure are inadequate.

6.Quality audits are not adequately conducted.

7.Executive Management Failed to ensure quality at all organisational level.

8.Procedures for conducting quality audits are inadequate.

9.Procedure for controlling design process are inadequate.

10.Procedure for design changes are inadequate or were not followed during design change Validation/Verification process.

 

Though these are old observations but each new emerging medical device company should very well use this guide so improvement can be done and sustained. Do not consider once done is over.

One must have master control solution to manage such problems like GXP process management software consists of configurable and easy to use software for automating so controls will be better.

 Even though you may create such system inhouse, it is recommended that USFDA consultant for medical devices may be consulted for adequacy of system itself.

IZielcan provide quick scalability of the skilled resources with knowledge of Design, Process Engineering & Validation, Systems Engineering, QMS and Regulatory to achieve outcome-based deliveries. The IZiel team comprises of experts in the Medical Device Industry and has a highly trained and experienced offshore team. This team not only consults but also helps in implementation of the solutions identified.