Guys working in FDA approved industry's has to know the following...
There are different forms those are issued by the FDA at the different stages of the regulatory audits. Different issues are communicated through these forms between FDA and the manufacturing facility. Some of them are:
1. FDA Form 482 - Notice of Inspection
2. FDA Form 483 - Observations of Inspection
3. FDA Form 484 - Receipt of Samples
4. FDA Form 463 - Affidavit
1. FDA Form 482 - Notice of Inspection:
It is an official notice of FDA for inspection signed by the FDA officials. It is produced by the inspector and has the authority to inspect the manufacturing facility. Inspection coordinator will receive the notice and manage the inspection accordingly. Coordinator should ask for notice, if it is not presented by the FDA inspector. A copy of this notice shall be attached with the inspection file.
Form 482 shows that inspector has authorization from FDA to inspect the facility. It clearly shows what the inspector may inspect including the area of inspection and documentation.
An inspector can ask for the manufacturing records of the regulated product and can enter in the area where the product is being manufactured. He can review online records, collect samples and interview the personnel working in area.
An inspector can’t review the product price list, financial data of firm, product marketing data, research documents and employee data excluding the training records. These documents are considered as firm’s confidential documents.
2. FDA Form 483 - Observations of Inspection:
Inspector shall provide the list of his observations about inspection on Form 483. It has all points noticed by the FDA inspectors. An observation made in previous inspection that is not corrected can be added in 483. The original copy of the FDA Form 483 is presented to the firm’s management, generally to the person who had received the Notice of Inspection.
3. FDA Form 484 - Receipt of Samples:
During the inspection if FDA inspectors want to take any sample, they have to issue a receipt of those samples on Form 484. it has quantity of sample with the lot number of the product sampled. Form 484 is used for samples only but not for promotional material, labels, photographs or any record taken by FDA investigators.
4. FDA Form 463 - Affidavit:
An affidavit is produced by the production authorities declaring the receipt and use of the raw material used in product manufacturing after the completion of the FDA audit.
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