We are going the wrong way!!!

Recently released 483 observation data from FDA for dietary supplement inspections show a troubling new trend in the retrograde direction.  Although it seems that the industry has finally got the message with identity testing of dietary ingredients (which has dropped to #9 on the top list for FY2017) there have been far more citations for failure to set proper specifications for finished products* than in any previous year. Other highly-cited observations are lack of written procedures for quality control and for product complaints.

Really folks – if you STILL need those basic SOPs and specifications created, please contact me!

CFR # Description # Observations
21 CFR 111.70(e)* Specifications – identity, purity, strength, composition 92
21 CFR 111.103 Written procedures – quality control operations 73
21 CFR 111.553 Written procedures – product complaint 63
21 CFR 111.75(c) Specifications met – verify; finished batch 61
21 CFR 111.205(a) Master manufacturing record – each batch 50
21 CFR 111.75(a)(2)(ii)(A) Component – qualify supplier 50
21 CFR 111.255(b) Batch record – complete 47
21 CFR 111.453 Written procedures – holding 46
21 CFR 111.75(a)(1)(i) Component – verify identity, dietary ingredient 45
21 CFR 111.70(b)(2) Specifications-component purity, strength, composition 44

FDA Disclaimer: These spreadsheets are not a comprehensive listing of all inspectional observations but represent the area of regulation and the number of times it was cited as an observation on an FDA Form 483 during inspections conducted by FDA and its representatives. Inspectional observations reflect data pulled from FDA’s electronic inspection tools. These tools are used to generate the FDA Form 483 when necessary. Not all FDA Form 483s are generated by these tools as some 483s are manually prepared.

*21 CFR 111.70(e) For each dietary supplement that you manufacture you must establish product specifications for the identity, purity, strength, and composition of the finished batch of the dietary supplement, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of the dietary supplement to ensure the quality of the dietary supplement.