Bell-More Labs, Inc
Form 483 issued April 3, 2024 · Hampstead, Maryland
- Inspection
- Mar 12 – Apr 3, 2024
- Investigators
- Andrew O. Ejiofor· Edmund F. Mrak· Frederick Razzaghi
- Observations
- 11
- Pages
- 18
- FEI number
- 1150023
In short: On April 3, 2024, FDA issued a Form 483 with 11 observations to Bell-More Labs, Inc in Hampstead, Maryland (FEI 1150023) after an inspection that ran Mar 12 – Apr 3, 2024. The investigators were Andrew O. Ejiofor, Edmund F. Mrak and Frederick Razzaghi. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 8 of 11 observations.
Most cited: 21 CFR 211.42 (4×) · 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 02
Drug product closures were not sterilized and processed to remove pyrogenic properties to assure that they…
- 03
Procedures designed to prevent microbiological contamination of ding products purporting to be sterile did not include…
- 04
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Andrew O. Ejiofor
5 documents · 2024–2025
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Georgia.
The firmBell-More Labs, 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 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Bell-More Labs, Inc?
FDA listed 11 observations on this Form 483, mostly about facilities & equipment, production and materials. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Bell-More Labs, Inc?
Andrew O. Ejiofor, Edmund F. Mrak and Frederick Razzaghi are named on this Form 483, for the inspection of Mar 12 – Apr 3, 2024. Each investigator has a profile showing what they cite most.
When was Bell-More Labs, Inc inspected by FDA?
The inspection ran Mar 12 – Apr 3, 2024, and the Form 483 is dated April 3, 2024.
How do I get the full Form 483 for Bell-More Labs, 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.