What is 483 USFDA observations? Detail information issued by the US FDAs 483 observation form.
US FDA is world one of best pharmaceutical regulatory agency, when it conducts any inspection and observe any discrepancy or violation with respect to the good manufacturing practices guidelines issued by US FDA, it provides the observations in a format which is predefined and the format number given by US FDA is 483, this format describes in details. The observations are given in this format when the inspector’s opinion confirms that the firm is in violation, the observations are very specific.
1) Is the observation regarding drugs or biological or medical devices, etc.?
2) Which manufacturing site it is the US FDA gives site ID to every manufacturing unit from which food and drugs are exported to the United states.
3) Reference number form the Guidance document, that is 21 CFR part211 is for drug products.
4) Short description of the observation.
5) Detailed description of the Observation.
6) Comment from the inspectors, and what they expect to be followed.
Do all observations are cited in Form 483 issued by the US FDA?
Only selective observations which are observed by inspectors are cited in 483 observation of USFDA, all observations are discussed by inspectors with management of the pharmaceutical company during closure meetings.
What is the purpose of giving 483 observations? What should be done after 483 Observations are received?
FDA expects that the company will take care of the violations observed and put in place corrective and preventive action so that these violations do not occur again.
A communication is required to provide to US FDA about the corrective and preventive actions taken, details of steps taken to meet the compliance, in predominant and as soon as possible.
USFDA 483 observation report is not the action taken by FDA against a pharmaceutical manufacturer, in 483 only few observations are cited, while all the list of observations is mentioned in establishment inspection report.
FDA doesn’t take any action based on only 483 observation forms, but the detailed establishment inspection report and the response from the pharmaceutical manufacturer all together are considered before taking any final action by the US FDA against any pharmaceutical manufacturing company.
Basic principles of clearing the US FDA audit without any serious observations are as follows.
1. Read the Good manufacturing practices, guidelines issued by US FDA, guidance documents that is 21 CFR for respective dosage and for respective guidelines like, sterile dosage form, Quality systems, etc.
2. Write SOPs of Production, operation, and maintenance, Quality assurance, Quality control, by keeping in view that.
A) Whatever is written in SOP is practicable and can be followed, and that fulfills the requirement of Guidance documents.
B) Train the manpower to follow the written procedures, if any deviations file the deviation report, if any changes to do it through Change management system, if any market complaints or quality issues arise, investigate properly, derive root cause and implement the corrective and preventive action to eliminate the root cause completely.
C) Manpower should be trained to follow the written procedures exactly, there should not be any deviation after this.
D) Maintain cleaning procedures and hygiene.
E) Documentation without any overwriting or any manipulation or and documentation must be written as the work happens there and there concurrently, without causing any delay.
F) All the principles of maintaining Data integrity must be followed.
These are a few simple steps, and honesty is at the heart of everything that the US FDA wants from every pharmaceutical manufacturer across the globe. It’s not at all difficult to maintain and follow, if your principle of doing business with the US is honest.
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[…] To understand how to do successful USFDA audit we must is understand why pharmaceutical companies are not able to cope up with the expectations of USFDA and land into the serious 483 observations. […]