How to prepare for an FDA inspection at a food plant in Puerto Rico

Who inspects food plants in Puerto Rico?

The FDA's Office of Inspections and Investigations (OII) carries out field inspections. In its inspectorate boundaries document (updated September 2024), the FDA places Puerto Rico in East Division 4 of its Office of Human Food Inspectorate (OHFI), together with Florida and the U.S. Virgin Islands.

OII's contacts page on fda.gov (updated October 6, 2026) confirms that grouping: the Division of Human Food Inspectorate East IV covers Florida, Puerto Rico and the Virgin Islands, and its office phone is 787-729-8588.

In August 2026, that same division (OHFI E-4) signed a partnership agreement with Puerto Rico's Department of Consumer Affairs (DACO) to share information, coordinate risk-based inspections and respond to emergencies. In other words, the FDA and DACO can coordinate their work, but each agency keeps its own authority.

Will you get advance notice?

Usually not. The FDA's Investigations Operations Manual (IOM), the investigators' primary reference, which is published for industry to consult, says pre-announcement is required for certain medical device inspections, but that pre-announcing food establishment inspections may generally be inappropriate, at the discretion of the program division.

When the FDA does give notice, the IOM says the purpose is to make sure the right people and records are available, not to set an appointment, and that notice for domestic inspections should generally be given no less than five calendar days ahead. Plan as if the visit will be unannounced.

On arrival: credentials and FDA Form 482

Under the 2026 IOM (section 5.1.4.1), the investigator shows their credentials to the most responsible person at the plant at the time. You may examine them and write down the number and name, but the manual does not allow them to be photocopied.

The investigator then issues a signed FDA Form 482, Notice of Inspection, to the most responsible person (section 5.1.4.2.1). If another FDA employee joins during the inspection, a new 482 signed by that person is issued.

During the inspection

The FDA explains that the investigator normally examines the production process, reviews certain records and collects samples. It recommends that a knowledgeable employee, such as the plant or production manager, preferably designated in advance, accompany the investigator at all times, and that staff ask if they do not understand what the investigator is doing.

If the investigator collects physical samples, the IOM says they must issue FDA Form 484, Receipt for Samples, before leaving the plant (section 5.1.4.2.3).

Records: what they can ask for and how fast

The Preventive Controls rule says all records required by Part 117 must be made promptly available for official review and copying when an authorized representative asks for them, orally or in writing (21 CFR 117.320).

Records are kept for at least 2 years. They may be stored offsite if they can be retrieved within 24 hours of a request for official review, except the food safety plan, which must stay onsite. An electronic record counts as onsite if it can be accessed from the plant (21 CFR 117.315).

For a plant with a food safety plan, the implementation records include (21 CFR 117.190):

• The justification when you decide not to establish a preventive control.
• Monitoring of preventive controls.
• Corrective actions.
• Verification: validation, verification of monitoring and corrective actions, instrument calibration, product testing, environmental monitoring, records review and reanalysis.
• The supply-chain program.
• Training of the PCQI and the qualified auditor.

At the close: FDA Form 483

If the investigator observed conditions that may violate the law, they issue FDA Form 483, Inspectional Observations, to management at the end of the inspection. The FDA explains that each observation is read and discussed with management, that the 483 is not an all-inclusive list of everything that could be wrong, and that it is not a final agency determination. The FDA evaluates it together with the inspection report, the evidence and the company's responses.

The FDA also says corrections made right away, in the investigator's presence, are seen as a positive sign. The IOM allows the status of each observation (for example, corrected or promised) to be annotated on the 483 at the division's discretion; it is voluntary for the company (section 5.5.11.4).

How to respond: the 15-business-day practice

The FDA recommends responding to the 483 in writing with a corrective action plan and implementing it promptly. In an August 11, 2009 Federal Register notice, the FDA stated that it generally allows 15 business days to respond to 483 observations, and that it normally will not delay a warning letter to review a response received after that period.

In March 2026 the FDA published a draft guidance that repeats the 15-business-day recommendation, but that draft is for drug CGMP inspections, not food. Use it as a best-practice reference, not as a rule for food plants.

A practical checklist to be ready any day

These steps follow from what the FDA and Part 117 say the investigator will look at and ask for:

• Designate in writing the person who will accompany the investigator, plus a backup, and rehearse what to do when they arrive.
• Keep the food safety plan onsite and check that it is signed and current.
• Check that monitoring, corrective action and verification records for the last 2 years are complete, signed and can be found in minutes.
• If you keep records offsite, confirm you can retrieve them within 24 hours.
• Set up a place where the investigator can review documents.
• Note what the investigator reviews, the samples they collect and the questions they ask, to prepare your response.
• If you receive a 483, prepare a written response with root cause, correction and evidence, and send it within 15 business days.