FDA 483 OBSERVATION · #184 OF 1,923 MOST-CITED

Master manufacturing record - unique formulation

FDA cited this observation 168 times across 160 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
Foods168
BY FISCAL YEAR
FY202422
FY202314
FY202214
FY20218
FY202010
FY201921
FY201830
FY201724
FY201625

What this observation is associated with

Firms cited for this observation also appear in FDA compliance actions — warning letters, injunctions, or seizures — at 4.1× the rate of the average FDA-cited firm (31.9% vs 7.8%), across 160 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.

M2 Ingredients, Inc. - Park Center · Vista, California · Foods · 2024-07-26

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

Quantum Fulfillment and Support, LLC · Cedar Creek, Texas · Foods · 2024-07-26

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

SUNYATA PRODUTOS ALTERNATIVOS LTDA · Atibaia · Foods · 2024-07-19

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

NeuroScience Solutions, Inc. · Osceola, Wisconsin · Foods · 2024-07-01

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

NOW Health Group Inc. · Bloomingdale, Illinois · Foods · 2024-06-27

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

I AM WELL HOLISTIC INC · Cleveland, Ohio · Foods · 2024-05-28

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 →