I just updated the charts with fresh data from FDA. Most food inspections are now occurring under new FSMA cGMPs (at 21 CFR 117) with the number of citations under the old food cGMPs being minimal.
Drilling down on the detail FSMA chart shows an increasing number of FDA 483s now contain observations related to hazard analysis and preventive controls. *Note: FDA FY 2019 ends on 9/30/19, the data are current as of 7/17/19)
| Subpart | Description | # Citations (FDA Fiscal YEAR 2019* to-date) |
|---|---|---|
| B | 117.35 – Sanitary operations. | 355 |
| B | 117.80 – Processes and controls. | 189 |
| B | 117.10 – Personnel. | 127 |
| B | 117.20 – Plant and grounds. | 119 |
| B | 117.40 – Equipment and utensils. | 110 |
| C | 117.130 – Hazard analysis. | 77 |
| C | 117.145 – Monitoring. | 69 |
| C | 117.135 – Preventive controls. | 66 |
| B | 117.37 – Sanitary facilities and controls. | 64 |
| A | 117.4 – Qualifications of individuals who manufacture, process, pack, or hold food. | 54 |
In addition, firms are being cited for new foreign supplier regulations (FSVP) under 21 CFR Part 1 (see below). This rule applies to all importers of food, including dietary supplement ingredients.
| CFR # | Short Description | Long Description | Frequency (TOTAL FOR ALL FISCAL YEARS) |
|---|---|---|---|
| 1.502(a) | Develop FSVP | You did not develop an FSVP. | 509 |
| 1.225 | Not registered | Your food facility is not registered as required. | 33 |
| 1.512(b)(2) | Develop FSVP | You did not develop an FSVP. | 31 |
| 1.504(a) | Hazard analysis written | You did not have a written hazard analysis to identify and evaluate known or reasonably foreseeable hazards. | 25 |
| 1.505(b) | Supplier approval – document | You did not document your approval of your foreign supplier. | 23 |
| 1.506(a)(1) | Procedures – establish, approve supplier | You did not establish written procedures to ensure that you import foods only from foreign suppliers you have approved based on an evaluation of the foreign supplier’s performance and the risk posed by the food. | 22 |
| 1.504(a) | Hazard analysis written | You did not have a written hazard analysis to identify and evaluate known or reasonably foreseeable hazards to determine whether there are any hazards requiring a control. | 19 |
| 1.505(a)(2) | Evaluation – performance, risk | You did not document the evaluation you conducted to determine a foreign supplier’s performance and the risk posed by a food. | 13 |