FDA 483 OBSERVATION · #218 OF 1,923 MOST-CITED

Master manufacturing record - prepared

FDA cited this observation 136 times across 135 firms in recent inspections. Below: how it breaks down by program area and fiscal year, and real examples of how FDA worded it on Form FDA 483.

What this grouping is not

An observation-type page groups FDA’s published citation records. The grouping, the compliance steps and the root causes are SPEQ synthesis, not an FDA classification of any citation, and a count measures what FDA published rather than risk.

BY PROGRAM AREA
Foods136
BY FISCAL YEAR
FY202658
FY202566
FY202412

What this observation is associated with

Firms cited for this observation also appear in FDA compliance actions — warning letters, injunctions, or seizures — at 1.7× the rate of the average FDA-cited firm (13.3% vs 7.8%), across 135 FEI-matched firms.

This is an association, not causation, and reflects co-occurrence in FDA's records — not a claim that the observation caused or preceded the action.

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How FDA worded it — real examples

You did not prepare a written master manufacturing record for each unique formulation of a dietary supplement that you manufactured and for each batch size of a dietary supplement that you manufactured.

SUNFLOWER NUTRACEUTICALS LLC · Hialeah, Florida · Foods · 2026-08-11

You did not prepare a written master manufacturing record for each unique formulation of a dietary supplement that you manufactured and for each batch size of a dietary supplement that you manufactured.

Sreedhareeyam Farmherbs India · Koothattukulam · Foods · 2026-08-05

You did not prepare a written master manufacturing record for each unique formulation of a dietary supplement that you manufactured and for each batch size of a dietary supplement that you manufactured.

kangyacare · Irvine, California · Foods · 2026-08-04

You did not prepare a written master manufacturing record.

Nutrixen Healthy LLC · City Of Industry, California · Foods · 2026-07-31

You did not prepare a written master manufacturing record for each batch size of a dietary supplement that you manufactured.

Streamline Manufacturing, LLC · Lindon, Utah · Foods · 2026-07-16

You did not prepare a written master manufacturing record for each batch size of a dietary supplement that you manufactured.

Krakatoa Inc (FL) · Palm Bay, Florida · Foods · 2026-07-14

Related SPEQ references

Where to read the requirements behind this observation area on SPEQ. These are SPEQ's topic and audience pages — not an FDA classification of the citation.

Food industry →

Examples are a representative sample of FDA's published inspection observations. Open the 483 observation explorer →