At the end of an FDA inspection, if the investigator saw conditions that in their judgment could make food adulterated, they hand management a Form FDA 483 listing the observations, and go through each one before leaving. A 483 isn't FDA's final decision: the agency weighs it with the investigator's report, the evidence and your response, then decides whether to do anything more, such as send a warning letter. That's why the response matters. FDA said in 2009 that it would review a response received within 15 business days of the 483 before deciding on a warning letter, and wouldn't ordinarily wait for one that came later. A good response takes each observation in turn: what you found, the cause, the correction already made, what prevents it happening again, and the evidence, such as photos, new procedures and training records. A 483 isn't a full list of everything wrong, either; you're expected to fix related problems it didn't name. In the example below, an Arkansas nut butter maker answers its first 483.
The short version
- A 483 lists conditions the investigator saw that could make food adulterated.
- It isn't FDA's final decision; your response is weighed with it.
- Respond in writing within 15 business days to have it considered before a warning letter.
- For each observation: the cause, the correction, the prevention and the evidence.
- Fix related problems the 483 didn't name.
- A warning letter asks for a response within a set time, often 15 working days.
- TaroStack keeps batches, lots and recalls on record. More below.
What happens after an inspection
| Step | What it is | Your part |
|---|---|---|
| Form 483 | The investigator's written observations, read and discussed with management at the close | Ask what each one means; note corrections made during the inspection |
| Your response | A written answer to each observation | Send it within 15 business days of the 483 |
| FDA's review | The 483, the inspection report, the evidence and your response | Keep fixing; send updates on corrections you promised |
| A warning letter, if one comes | FDA's notice of significant violations | A written response within the time it sets, often 15 working days |
| No more action | FDA decides nothing further is needed | Keep the records of what you fixed |
What FDA expects of a food plant is in 21 cfr 117 subpart b, and writing up each fix in corrective action form.
The rules
| Rule | Where |
|---|---|
| The written report | Before leaving, the investigator gives the owner, operator or agent in charge a written report of conditions that in their judgment indicate food is filthy, putrid or decomposed, or was prepared, packed or held under insanitary conditions (21 U.S.C. 374(b)) |
| What it means | Not a final agency determination; weighed with the inspection report, evidence and the company's responses; companies are encouraged to respond in writing with a corrective action plan (FDA, Form 483 FAQ) |
| 15 business days | FDA said it would review a response received within 15 business days before deciding on a warning letter, and wouldn't ordinarily delay a letter for one received later (74 FR 40211, 2009) |
| Warning letters | Request correction and a written response within a set time, often 15 working days (FDA Regulatory Procedures Manual, chapter 4) |
This is general information, not legal advice.
An example: four observations
Red Oak Nut Butters, the made-up nut butter maker in Little Rock, Arkansas, I use in these examples, had its first FDA inspection in September. The investigator left a 483 with four observations, and the owner answered each one in 12 business days:
| Observation | Cause | Correction | Prevention and evidence |
|---|---|---|---|
| 1. Peanuts received without checking the supplier's documents for the lot | No written receiving procedure | Held the open lot until the supplier's lab results came | A receiving procedure and log, and the receiver trained; copies attached |
| 2. Grinder not cleaned between the peanut and almond runs | Almond ran after peanut on busy days | Almond runs moved to Mondays, before any peanut | The new schedule and six weeks of cleaning records |
| 3. Hand sink by the grinder blocked by cases | Too little storage space | Cases moved to a new rack | Photos of the clear sink; a daily check on the opening list |
| 4. No roaster temperature record for two lots | A broken thermometer wasn't replaced | A new thermometer, calibrated | The roasting log for every lot since, and a spare thermometer |
The response went in within the 15 business days, with a cover letter from the owner, one section per observation, and the evidence attached. The owner also checked the cashew line, which the 483 didn't mention, and found the same cleaning gap, and fixed it the same way. No warning letter followed. Had a lot gone out under those conditions and needed to come back, how FDA classes recalls is in fda recall classification.
Get the checker
Download the 483 response tracker. One sheet: each observation, what the investigator wrote, the cause, the correction, the prevention and the evidence; type the due and done dates and the status fills in from today's date. It's an ordinary Excel file with no macros, and it works in Google Sheets, LibreOffice and Numbers.
Where this stops working
The tracker keeps the response in order. What the investigator asks to see next time, which lots were made before the fix and which after, and who bought them, comes from the records behind it.
How TaroStack does it
TaroStack keeps batches, lots and recalls on record, so which lots were made before a fix is a report, not a search.
Batches by lot. Each batch records its date, the ingredient lots it used and how much it made, so lots made before and after a fix are easy to tell apart.
Receiving by supplier and lot. Each delivery of peanuts is received from its supplier with its lot.
Recalls. If a lot made before the fix has to come back, one report shows every customer who got it.
| The job | Notebook | In TaroStack |
|---|---|---|
| Lots made before a fix | Searched by hand | Batches by date |
| Which peanut lot went into a batch | A notebook | Batches by lot |
| Who got a lot | Invoices | One recall report |
Receiving, batches, lots and recalls are on every plan, from $49 a month. The first 30 days are free, with no credit card. If you'd like a hand setting up, ask, and we'll do it with you.