FDA inspection

Pests and sanitation problems top the list of the FDA’s most frequently cited inspection observations in food facilities for FY 2017.

The list, released last month, aggregates the observations cited on FDA Form 483s, which are filed “when, in an investigator’s judgment, the observed conditions or practices indicate that an FDA-regulated product may be in violation of FDA’s requirements.”

There were just over 10,000 observations recorded last year. However, this number is likely an underestimate as it includes only Form 483s that were generated using the agency’s electronic inspection tools, not those generated manually or using other tools.

Overall, 8 of the top 10 violations remained the same from the previous year. Falling off the list were “importer verification” and “food safety hazards,” while the “cleaning and sanitizing operations” and “harborage areas” made their way into the top 10.

Here are the top 10 most frequently cited FDA violations in the food industry for BY 2017.

1. Lack of effective pest control

Reference number: 21 CFR 110.35(c)
Observations: 330
Description: Effective measures are not being taken to [exclude pests from the processing areas] [protect against the contamination of food on the premises by pests].

A lack of effective measures to keep pests out of processing areas and protect against contamination of food by pests has been the top violation since FY 2009.

2. Screening

Reference number: 21 CFR 110.20(b)(7)
Observations: 211
Description: Failure to provide adequate screening or other protection against pests.

Related to #1, this observation falls under plant construction and design.

3. Sanitation monitoring

Reference number: 21 CFR 123.11(b)
Observations: 203
Description: You are not monitoring the sanitation conditions and practices with sufficient frequency to assure conformance with Current Good Manufacturing Practices.

This citation covers the following:

  • Safety of water that comes into contact with food or food contact surfaces, including water used to manufacture ice
  • Condition and cleanliness of food contact surfaces
  • Prevention of cross-contamination from insanitary objects
  • Maintenance of hand washing, hand sanitizing, and toilet facilities
  • Protection of food, food packaging material, and food contact surfaces from adulteration
  • Proper labeling, storage and use of toxic chemicals
  • Control of employee health conditions
  • Exclusion of pests

4. Floors, walls, and ceilings

Reference number: 21 CFR 110.20(b)(4)
Observations: 192
Description: The plant is not constructed in such a manner as to allow [floors] [walls] [ceilings] to be [adequately cleaned and kept clean] [kept in good repair].

Violations in this category include failing to keep condensate from dripping from fixtures and having work spaces that are too small for employees to perform their duties without risk of contamination.

5. Buildings/sanitary

Reference number: 21 CFR 110.35(a)
Observations: 176
Description: Failure to maintain buildings, fixtures, or other physical facilities in a sanitary condition.

This refers to the general maintenance of facilities.

6. HACCP plan implementation

Reference number: 21 CFR 123.6(b)
Observations: 162
Description: You did not implement the [monitoring] [recordkeeping] [verification] procedures listed in your HACCP plan.

Having a written HACCP plan is a good first step, but that plan needs to be implemented. Although this violation fell from #6 to #7 in FY 2017, the number of observations increased 9%, from 148 to 162.

7. Cleaning and sanitizing operations

Reference number: 21 CFR 110.35(a)
Observations: 157
Description: Failure to conduct cleaning and sanitizing operations for utensils and equipment in a manner that protects against contamination of [food] [food-contact surfaces] [food-packaging materials].

This is another category of violations falling under the same code section referenced in #5. There’s a third category, “buildings/good repair.” In total, there were 451 citations issued for 21 CFR 110.35(a).

8. Manufacturing conditions

Reference number: 21 CFR 110.80(b)(2)
Observations: 156
Description: Failure to [manufacture] [package] [store] foods under conditions and controls necessary to minimize [the potential for growth of microorganisms] [contamination].

Processors can comply with this requirement by monitoring physical factors such as time, temperature, humidity, aw, pH, pressure, flow rate, and manufacturing operations such as freezing, dehydration, heat processing, acidification, and refrigeration.

9. Reasonable precautions

Reference number: 21 CFR 110.80
Observations: 146
Description: All reasonable precautions are not taken to ensure that production procedures do not contribute contamination from any source.

Reasonable precautions in this context include controls such as production scheduling (e.g., sequencing products to prevent cross-contamination) and proper cleaning.

10. Harborage areas

Reference number: 21 CFR 110.20(a)(1)
Observations: 137
Description: Failure to [properly store equipment] [remove litter and waste] [cut weeds or grass] that may constitute an attractant, breeding place, or harborage area for pests, within the immediate vicinity of the plant buildings or structures.

Rounding out the top 10 is another pest-related violation — a failure to properly maintain the grounds to discourage them from hanging around.

Download the full spreadsheet and access the summaries of inspection observations by fiscal year here.

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