Failure of the review process is the root cause of many NCs.
Whether it is any area. Let's discuss a few examples of drug listing of this case study;
1. The firm has submitted contradictory information between the labeling and the electronic listing file. (Violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
2. Name and quantity of each active pharmaceutical ingredient as required under section 510 j(1)(C) and 21 CFR 207.49(a)(4) missing.
3. The active ingredients included in the labeling do not match the active ingredient included in the electronic listing file (SPL). Specifically, the active ingredients described on the carton label.
4. Section 510(j)(1)(B)(i) and the listing requirements under 21 CFR 207.49 (a)(15)(ii) also state that all current labeling except that only one representative container or carton label need to be submitted where differences exist only in the quantity of contents statement or the bar code.
5. The image uploaded into the FDA’s electronic Drug Registration and Listing System (eDRLS) does not appear to be an image of the product’s label. Specifically, the carton label refers to a syrup containing dextromethorphan and guaifenesin, but the Drug Facts section of the labeling includes loratadine tablets indicated for allergic rhinitis, while the listing SPL refers to propylene glycol as active ingredient.
6. Under section 510(j) of the FD&C Act, and the drug listing requirements under 207.49 (a)(2), the package type and volume information should correspond to the package code segment of the NDC. For your product XYZ, the package description found in the labeling does not match the description found in the packaging section of the electronic listing file, specifically, the carton label image includes the size as 118 ml, while the electronic listing file includes the size as 1 U in 1 bottle.
What is to be concluded?
Whether this warning letter could be avoided?
Do you think these observations are very technical or serious that one cannot review and identify?
It might be in a hurry this information might have been uploaded without review...
So what do you conclude from this?