Crosbys Drugs Inc.
Form 483 issued September 16, 2016 · Columbus, Ohio
- Inspection
- Sep 12 – Sep 16, 2016
- Investigator
- Matthew B. Casale
- Observations
- 8
- Pages
- 3
- FEI number
- 1530045
In short: On September 16, 2016, FDA issued a Form 483 with 8 observations to Crosbys Drugs Inc. in Columbus, Ohio (FEI 1530045) after an inspection that ran Sep 12 – Sep 16, 2016. The investigator was Matthew B. Casale. Most observations concern production and materials; the most-cited regulation is 21 CFR 211.94 (drug product containers and closures).
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of dmg products pmporting to be sterile are not…
- 02
Clothing of personnel engaged in the manufacturing, processing and packing of drug products is not appropriate…
- 03
Dmg product containers and closures were not clean and sterilized and processed to remove pyrogenic properties…
- 04
The flow of components and in-process materials though the building is not…
This inspection in context
Matthew B. Casale
29 documents · 2015–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Ohio.
The firmCrosbys Drugs Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Crosbys Drugs Inc.?
FDA listed 8 observations on this Form 483, mostly about production, materials and facilities & equipment. The most-cited regulation is 21 CFR 211.94 (drug product containers and closures). The opening words of each observation are shown on this page.
Who inspected Crosbys Drugs Inc.?
Matthew B. Casale is named on this Form 483, for the inspection of Sep 12 – Sep 16, 2016. Each investigator has a profile showing what they cite most.
When was Crosbys Drugs Inc. inspected by FDA?
The inspection ran Sep 12 – Sep 16, 2016, and the Form 483 is dated September 16, 2016.
How do I get the full Form 483 for Crosbys Drugs Inc.?
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