Crosbys Drugs Inc.
Form 483 issued September 30, 2021 · Columbus, Ohio
- Inspection
- Sep 9 – Sep 30, 2021
- Investigator
- Ucheabuchi C. Chudi-Nwankwor
- Observations
- 8
- Pages
- 5
- FEI number
- 1530045
In short: On September 30, 2021, FDA issued a Form 483 with 8 observations to Crosbys Drugs Inc. in Columbus, Ohio (FEI 1530045) after an inspection that ran Sep 9 – Sep 30, 2021. The investigator was Ucheabuchi C. Chudi-Nwankwor. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and facilities & equipment account for 7 of 7 observations.
Most cited: 21 CFR 211.113 (4×) · 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
_,). __ _ _ __,I testing o~(b) (4)] used to sterilize drug products. Your…
- 03
Non sterilized, non-depyrogenated equipment used…
- 04
Disinfectant contact time (also known as "dwell time") and coverage of the item being disinfected were…
- 05
Personnel engaged in aseptic processing were observed leaving and re-entering the clean room without…
This inspection in context
Ucheabuchi C. Chudi-Nwankwor
22 documents · 2016–2026
Cites 211.22 (responsibilities of quality control unit) 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
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 and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Crosbys Drugs Inc.?
Ucheabuchi C. Chudi-Nwankwor is named on this Form 483, for the inspection of Sep 9 – Sep 30, 2021. Each investigator has a profile showing what they cite most.
When was Crosbys Drugs Inc. inspected by FDA?
The inspection ran Sep 9 – Sep 30, 2021, and the Form 483 is dated September 30, 2021.
How do I get the full Form 483 for Crosbys Drugs Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.