FDA 483 OBSERVATION · #1242 OF 1,932 MOST-CITED

Retention of records

FDA cited this observation 12 times across 12 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
Bioresearch Monitoring12
BY FISCAL YEAR
FY20241
FY20224
FY20194
FY20181
FY20162

How FDA worded it — real examples

Records required by 21 CFR 56 have not been maintained for three years following completion of the research.

Saint Francis Medical Center · Cape Girardeau, Missouri · Bioresearch Monitoring · 2024-02-22

Records required by 21 CFR 56 have not been maintained for three years following completion of the research.

St. Agnes Medical Center IRB · Fresno, California · Bioresearch Monitoring · 2022-09-01

Records required by 21 CFR 56 have not been maintained for three years following completion of the research.

Ascension Sacred Heart Hospital IRB · Pensacola, Florida · Bioresearch Monitoring · 2022-08-10

Records required by 21 CFR 56 have not been maintained for three years following completion of the research.

Creighton University IRB · Omaha, Nebraska · Bioresearch Monitoring · 2022-04-07

Records required by 21 CFR 56 have not been maintained for three years following completion of the research.

Robert Wood Johnson U Hosp @ Hamilton IRB · Hamilton, New Jersey · Bioresearch Monitoring · 2021-12-22

Records required by 21 CFR 56 have not been maintained for three years following completion of the research.

Avera IRB · Sioux Falls, South Dakota · Bioresearch Monitoring · 2019-07-10

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.

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