FDA inspections in Puerto Rico: data and how to prepare

What NAI, VAI and OAI mean

When an inspection closes, FDA classifies the result for each inspected area with one of three classifications:

NAI: No Action Indicated

The facility is in an acceptable state of compliance. It usually was not issued a Form FDA 483 at the end of the inspection.

VAI: Voluntary Action Indicated

The inspection found objectionable conditions or practices, but the agency determined the facility can correct them voluntarily and will not recommend any action. It usually was issued a Form FDA 483.

OAI: Official Action Indicated

The facility is in an unacceptable state of compliance. It may have been issued a Form FDA 483.

Data as of November 11, 2026. Source: FDA: Inspections Database Frequently Asked Questions.

Food inspections in Puerto Rico by fiscal year

The federal fiscal year runs October 1 to September 30. Each inspection counts once, with its most serious classification (OAI, then VAI, then NAI).

Data as of November 11, 2026. Source: FDA Data Dashboard: Inspections and citations. FDA only publishes inspections with a final classification and does not include state contract inspections, so the most recent years can still grow.

What a Form FDA 483 is

It is the document the investigator gives management at the end of an inspection when they observed conditions that, in their judgment, may constitute violations of the Federal Food, Drug, and Cosmetic Act. Each observation is read and discussed with management.

A 483 is not a final agency determination, nor a list of every possible deficiency. FDA weighs it with the Establishment Inspection Report (EIR), the evidence collected and the company's response, and encourages companies to respond in writing with their corrective action plan and implement it expeditiously.

Data as of November 11, 2026. Source: FDA: FDA Form 483 Frequently Asked Questions.

Most cited sections in Puerto Rico (fiscal years 2022–2026)

Of the 447 food inspections in the period, 228 appear with citations in FDA's data. The table counts how many inspections cited each section of the regulations at least once.

Data as of November 11, 2026. Source: FDA Data Dashboard: Inspections and citations. The citations data only includes 483s prepared with FDA's electronic tools; manually prepared 483s are missing. So these counts are a floor, not the total of 483s issued.

1. Pest control (21 CFR 117.35(c))

   Pests are not allowed in any area of the plant. Effective measures must keep them out of manufacturing, packing and holding areas, and pesticides may be used only with precautions that protect food, food-contact surfaces and packaging.

   Read the rule: 21 CFR 117.35(c)

2. Warehousing and distribution (21 CFR 117.93)

   Food must be stored and transported under conditions that protect it against allergen cross-contact, biological, chemical and physical contamination, and deterioration of the food and its container.

   Read the rule: 21 CFR 117.93

3. Plant maintenance and sanitation (21 CFR 117.35(a))

   Buildings, fixtures and other facilities must be kept clean, sanitary and in good repair. Utensils and equipment must be cleaned and sanitized in a way that protects against contamination and allergen cross-contact.

   Read the rule: 21 CFR 117.35(a)

4. Foreign Supplier Verification Program (FSVP) (21 CFR 1.502(a))

   An importer must develop, maintain and follow an FSVP for each food it imports, giving adequate assurances that the foreign supplier produces it with at least the level of public health protection FDA rules require.

   Read the rule: 21 CFR 1.502(a)

5. Manufacturing operations controls (21 CFR 117.80(c))

   Equipment, utensils and containers must be kept clean and sanitized, and all manufacturing, packing and holding must run under conditions and controls that minimize microbial growth, allergen cross-contact, contamination and deterioration.

   Read the rule: 21 CFR 117.80(c)

6. Sanitary facilities (21 CFR 117.37)

   The plant must have adequate sanitary facilities: safe water from an adequate source, properly designed and maintained plumbing and drainage, sewage disposal, toilet and hand-washing facilities, and rubbish disposal.

   Read the rule: 21 CFR 117.37

7. Plant construction and design (21 CFR 117.20(b))

   The plant must be suitable in size, construction and design to make maintenance and sanitary operations possible, starting with enough space for equipment and materials.

   Read the rule: 21 CFR 117.20(b)

8. Preventive controls (21 CFR 117.135(a)(1))

   The facility must identify and implement preventive controls so that hazards requiring them are significantly minimized or prevented. The rule also requires them to be written (117.135(b)).

   Read the rule: 21 CFR 117.135(a)(1)

9. Personnel (21 CFR 117.10)

   Management must take reasonable measures for disease control (excluding anyone who could contaminate food) and to make sure staff in contact with food follow hygienic practices.

   Read the rule: 21 CFR 117.10

10. Hazard analysis (21 CFR 117.130(a)(1))

    The facility must conduct a hazard analysis to identify and evaluate known or reasonably foreseeable hazards for each type of food and decide which require a preventive control. It must be written, whatever the outcome (117.130(a)(2)).

    Read the rule: 21 CFR 117.130(a)(1)

Food recalls by Puerto Rico companies

A recall is a firm's action to remove a product from the market, on its own initiative, at FDA's request or by FDA order. One recall event can include several products. FDA classifies each recalled product as:

• Class I: there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death.
• Class II: the product may cause temporary or medically reversible health consequences, or the probability of serious consequences is remote.
• Class III: the product is not likely to cause adverse health consequences.

Data as of November 11, 2026. Source: openFDA: Food Enforcement Reports (food recalls); FDA: Recalls Background and Definitions. Calendar year. 2026 includes recalls published in openFDA through November 4, 2026.

How to prepare for an inspection

Based on the sections cited most often in Puerto Rico and on what FDA says about the 483, these are concrete points to check:

• Pest control (21 CFR 117.35(c)): measures that keep pests out of manufacturing, packing and holding areas are effective, and pesticide use protects the food.
• Storage and transport (21 CFR 117.93): conditions protect against contamination, allergen cross-contact and deterioration of food and containers.
• Maintenance and sanitation (21 CFR 117.35(a) and 117.37): buildings in good repair, equipment cleaned and sanitized, safe water, adequate hand-washing and toilet facilities.
• If your facility must have a food safety plan under part 117: the hazard analysis and preventive controls are written and implemented (21 CFR 117.130 and 117.135).
• If you import food: you have an FSVP for each food you import (21 CFR 1.502).
• If you receive a 483: respond in writing with your corrective action plan and put it in place expeditiously, as FDA recommends.
• Review our answers, with official sources, on records and inspections. See questions and guides
• See how ready your plant is with the free self-assessment. Take the self-assessment