FDA 483 OBSERVATION · #197 OF 1,923 MOST-CITED

Microbiological testing

FDA cited this observation 152 times across 142 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
Drugs152
BY FISCAL YEAR
FY20268
FY202520
FY20249
FY202310
FY202222
FY20215
FY20206
FY201917
FY201812
FY201727
FY201616

What this observation is associated with

Firms cited for this observation also appear in FDA compliance actions — warning letters, injunctions, or seizures — at 5.6× the rate of the average FDA-cited firm (43.7% vs 7.8%), across 142 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

Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing.

Inspec Solutions LLC · Holly Hill, Florida · Drugs · 2026-06-12

Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing.

Unither Manufacturing LLC. · Rochester, New York · Drugs · 2026-05-15

Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing.

GVS TM, Inc · Covina, California · Drugs · 2026-05-01

Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing.

Kingdomway Health Sciences LLC · Casa Grande, Arizona · Drugs · 2025-12-03

Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing.

Weckerle Cosmetics USA, INC · Torrance, California · Drugs · 2025-10-31

Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing.

Catalent Greenville Inc · Greenville, North Carolina · Drugs · 2025-10-24

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.

Contamination control →Pharma industry →

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