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FDA Inspection Citations: FSMA

I recently uploaded the latest FDA 483 citations spreadsheet which includes an increasing number of citations for FSMA-related inspections (as defined by 21 CFR  Part 117).  The data are current thru 2/15/2018.    At present the list of most popular observations resembles the old 110 food cGMPs, but there are 10 citations (out of a total of 856 under the new FSMA cGMPs) for problems with hazard analysis and control, indicating FDA is starting to require hazard analysis and food safety plans (if indicated by the hazard analysis, i.e. 117.130(a)(1) Your hazard analysis did not identify a known or reasonably foreseeable hazard that required a preventive control.)

If you are subject to the FSMA regulations on Preventive Controls, this might be a good time to start working on them!

CFR # Short Description Long Description Frequency Cited
117.1 Personnel You did not take a reasonable measure and precaution related to personnel practices. 78
117.4 Equipment and Utensils – Design and Maintenance Your equipment and utensils were not designed and constructed to be adequately cleaned or maintained to protect against contamination. 66
117.35(c) Pest Control You did not exclude pests from your food plant to protect against contamination of food. 54
117.37 Sanitary Facilities and Control Your plant did not have adequate sanitary facilities and accommodations. 47
117.80(c) Manufacturing, Processing, Packing, Holding – Controls You did not conduct operations under conditions and controls necessary to minimize the potential for contamination of food. 42
117.35(a) Sanitary Operations – Plant Maintenance You did not maintain your plant in a clean and sanitary condition and keep your plant in repair. 29
117.35(a) Sanitary Operations – Plant Sanitation You did not clean and sanitize your utensils or equipment in a manner that protects against contamination. 25
117.35(d) Sanitation of food contact surfaces – frequency You did not clean and sanitize your utensils or equipment as frequently as necessary to protect against contamination of food. 25
117.35(e) Sanitation of non-food contact surfaces – frequency You did not clean your non-food contact surface in a manner and as frequently as necessary to protect against contamination. 24
117.20(b) Plant Construction and Design Your plant was not constructed to facilitate maintenance and sanitary operations. 20
117.35(a) Sanitary Operations – Plant Maintenance You did not keep your plant in repair. 19
117.20(a) Grounds You did not keep the grounds around your plant in a condition that would protect against the contamination of food. 16
117.35(b)(1) Cleaning and sanitizing substances- safe and adequate You did not ensure that your cleaning compounds and sanitizing agents are safe and adequate under the conditions of use. 16
117.80(c) Manufacturing, Processing, Packing, Holding – Controls You did not conduct operations under conditions and controls necessary to minimize the potential for growth of microorganisms and contamination of food. 16
117.20(b) Plant Construction and Design Your plant was not constructed and designed to facilitate maintenance and sanitary operations. 16
117.35(a) Sanitary Operations – Plant Maintenance You did not maintain your plant in a clean and sanitary condition. 15
117.93 Storage and Transportation You did not store or transport food, including ingredients, under conditions that protect against contamination. 12
117.130(a)(1) Hazard Analysis – Identification of Hazard Your hazard analysis did not identify a known or reasonably foreseeable hazard that required a preventive control. 10
117.20(b) Plant Construction and Design Your plant was not designed to facilitate maintenance and sanitary operations. 10

Note: My Top 25 dietary supplement citations chart now reflects 483 data up to mid-February 2018, and will continue to reflect the latest data as it is posted by FDA.

FDA Releases FY2017 Inspection Observations

 

CFR # Description # Obs.
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 111.75(a)(2)(ii)(A) Component – qualify supplier 50
21 CFR 111.205(a) Master manufacturing record – each batch 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

Late last year FDA released inspection observations (483 citations) for FY 2017.  The table above shows the top 10 dietary supplement (21 CFR Part 111 cGMP) inspection observations found during inspections in FY17.  Significantly, failure to verify the identity of all dietary ingredients has now dropped to 9th place, down from 2nd place in FY 2016.  Lack of established specifications for identity, purity, strength, and composition of finished dietary supplements continues to be a problem found at a large number of firms. Failing to establish written procedures for quality control operations moved up to #2. Subpart E observations (for Production and Process Control) together made up nearly 34% of the total observations by FDA inspectors, continuing the trend upward of the past few fiscal years.

NO! NO! NO!

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.

FDA Releases 2017 Inspection Classifications

FDA just released fiscal year 2017 inspection classification data.  The data show that inspections of dietary supplement firms appeared to have less problems in 2017 than prior years.  The rate of OAI (official action indicated) classifications dropped to less than 4%, compared with around 8% in FY 2016 for the project area Food Composition, Standards, Labeling and Economics, under which most 21 CFR Part 111 cGMP inspections occur (but see Disclaimer below before you celebrate, these figures may change over time).  Perhaps it is better to focus on the success rate – NAI (no action indicated, no 483 issued) inspections went up to over 60% of the total, compared with just over 50% in FY 2016.

FDA also announced they will now update inspections data on a monthly basis: “NEW: Beginning in mid-November 2017, the Inspections Classifications dataset will be updated monthly.

This is good news if you need to look up the status of any FDA-regulated firm in their online database (but bad news if, like me, you compile charts based on those datasets – now I have to update monthly!)

FDA Disclaimer: “The disclosure of this information is not intended to interfere with planned enforcement actions, therefore some information may be withheld from posting until such action is taken. Therefore, this database does not represent a comprehensive listing of all conducted inspections and should not be used a source to compile official counts.

Inspections are classified (see Inspection Classifications) to reflect the compliance status of a firm. Classifications are based upon findings identified during an inspection and Agency review for compliance. During the Agency assessment, classifications may be subject to change after a review of all relevant information. To maintain current knowledge of a firm’s compliance status, it may be important to recheck the Inspections Database for updates.”

 

483 Reverse Lookup – Food and Drugs Added

If you have been a recipient of a Form 483 from FDA, you may be familiar with the fact that the citations for specific cGMPs are not included on the form at the end of an inspection (unlike Warning Letters).  Some time ago I created a reverse lookup form so that you can type in partial text from the 483 and display matching citations for dietary supplement inspections.  I just expanded this page to include reverse lookups for 21 CFR Parts 211 (drugs), 117 (FSMA, foods) and the old food cGMPs, Part 110.  There are currently very few citations for 117, but I expect more to be released for FY 2017, later this Fall.

 

 

NEW Regulatory Action Reports Now Available Online

Regulatory Action Reports (click link for an example) are now available for individual firms as an automated service on my website.

Reports include data on recalls, Warning Letters, inspections, Form 483 observations and tainted products (products that are sold as dietary supplements but may contain one or more prescription drugs).  They include charts showing classes of recalls, score of actual inspection outcomes vs. typical inspection outcomes, and inspection citations and classifications if released by FDA1.

The data are culled from various FDA databases and OpenFDA and updated regularly as new data are issued by FDA.  Access the query form at:  https://www.marianboardley.com/research/

Cost for a report on one firm starts at $19.99.  In some cases, you will be able to combine multiple firms or firm names on a single report at a discount rate. I accept PayPal, and all major credit cards via PayPal (you do not need a PayPal account)

PayPal Acceptance Mark

Queries for Recalls and SAERs from data posted by OpenFDA are still free!

1  If FDA regulatory action is pending, or FDA has not yet inspected a firm, there may be no data available in my database. You will get a preliminary assessment of available data on the firm before you pay for the report.

FDA inspections show improvement among Dietary Supplement Firms in 2016

 

CFSAN Classifications 1

FDA Releases FY 2016 Inspection Classifications

Despite continued bemoaning of lack of compliance in the dietary supplement industry, along with ‘dark issues’ of business journals and generally bad press, in fact, data released by FDA show that dietary supplement firms’ track record during some inspections may actually be improving.

The total number of inspections in the project area covering most dietary supplement inspections declined in FY 2016, but the percentage of inspections resulting in a ‘No Action Indicated’  (NAI) classification went up, while the number of inspections resulting in ‘Official Action Indicated’ (OAI)  declined again in FY 2016 to 35 firms in total (see chart above).  What this means is that FDA have been issuing less 483s in this project area at the conclusion of their inspections, and that they are not having to take follow-up actions, such as Warning Letters, as often as they were doing previously.  This trend continues the progress of the previous two fiscal years with more than 50% of firms getting clean inspections in this area.  Clearly more room for improvement exists.

 

CFSAN Classifications 2

The second chart shows the percentage of inspections for each classification on a 100% scale, which illustrates year-on-year improvement by eliminating the variation in the total number of inspections per year.

Charts for other FDA project areas can be found at my web site.

All charts are © Marian Boardley Consulting LLC.  Please ask for permission before using.  Thanks!

FDA Releases FY 2016 Inspection Observations

FDA

FDA has just released inspection observations for FY 2016. Preliminary data (see chart above) show that the total number of inspectional observations for dietary supplement cGMPs rose in FY 2016, having declined for the previous several fiscal years.

The most commonly cited observation in FY 2016 was once again failure to set appropriate specifications for finished dietary supplements, namely 21 CFR Sect. 111.70(e) Specifications – identity, purity, strength, composition.

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