BC3 TECHNOLOGIES
Form 483 issued November 26, 2024 · Baltimore, Maryland
- Inspection
- Nov 22 – Nov 26, 2024
- Investigator
- Christina D. Mello
- Observations
- 8
- Pages
- 5
- FEI number
- 3026322855
In short: On November 26, 2024, FDA issued a Form 483 with 8 observations to BC3 TECHNOLOGIES in Baltimore, Maryland (FEI 3026322855) after an inspection that ran Nov 22 – Nov 26, 2024. The investigator was Christina D. Mello. Most observations concern production & process controls and cAPA; the most-cited regulation is 21 CFR 820.198 (complaint files).
At a glance
Production & process controls and capa account for 6 of 8 observations.
What FDA observed
Preview: the opening words of each observation- 01
Device packaging and/or shipping containers are not designed and constructed to protect the device from alteration…
- 02
Records of complaint investigations are not maintained by…
- 03
Requirements that must be met by suppliers have…
- 04
Design output was not…
This inspection in context
Christina D. Mello
1 document · 2024
Cites 820.198(a) (complaint files) more than any other section. Most of their documents are for sites in Maryland.
The firmBC3 TECHNOLOGIES history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.130
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at BC3 TECHNOLOGIES?
FDA listed 8 observations on this Form 483, mostly about production & process controls, cAPA and design controls. The most-cited regulation is 21 CFR 820.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected BC3 TECHNOLOGIES?
Christina D. Mello is named on this Form 483, for the inspection of Nov 22 – Nov 26, 2024. Each investigator has a profile showing what they cite most.
When was BC3 TECHNOLOGIES inspected by FDA?
The inspection ran Nov 22 – Nov 26, 2024, and the Form 483 is dated November 26, 2024.
How do I get the full Form 483 for BC3 TECHNOLOGIES?
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.