← 483 OBSERVATION EXPLORER

FDA 483 OBSERVATION · #694 OF 1,000 MOST-CITED

Non-microbial contamination, production area

FDA cited this observation 24 times across 23 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.

BY PROGRAM AREA
Drugs24
BY FISCAL YEAR
FY20235
FY20226
FY20215
FY20202
FY20195
FY20181

How FDA worded it — real examples

Non-microbial contamination was observed in your production area.

Snf Holdings, LLC · Livonia, Michigan · Drugs · 2023-03-02

Non-microbial contamination was observed in your production area.

Purformance Wellness Pharmacy LLC dba Seven Cells · Stuart, Florida · Drugs · 2022-12-09

Non-microbial contamination was observed in your production area.

Northern VA Compounders PLLC · Sterling, Virginia · Drugs · 2022-12-09

Non-microbial contamination was observed in your production area.

Barclay, Luke, & Pillai Specialty Pharmacy, PLLC · Las Vegas, Nevada · Drugs · 2022-12-09

Non-microbial contamination was observed in your production area.

CareFirst Specialty Pharmacy LLC · Mount Laurel, New Jersey · Drugs · 2022-11-30

Non-microbial contamination was observed in your production area.

South Berwick Pharmacy Seacoast Compounding, Inc. · South Berwick, Maine · Drugs · 2022-09-30

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 controlPharma industry

Examples are a representative sample of FDA's published inspection observations. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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