Maiden Biosciences
Form 483 issued November 28, 2022 · Gaithersburg, Maryland
- Inspection
- Nov 21 – Nov 28, 2022
- Investigator
- Jude C. Dike
- Observations
- 2
- Pages
- 5
- FEI number
- 3012973796
In short: On November 28, 2022, FDA issued a Form 483 with 2 observations to Maiden Biosciences in Gaithersburg, Maryland (FEI 3012973796) after an inspection that ran Nov 21 – Nov 28, 2022. The investigator was Jude C. Dike. Most observations concern management controls; the most-cited regulation is 21 CFR 820.20 (management responsibility).
At a glance
2 of 2 observations on this 483 concern management controls.
Most cited: 21 CFR 820.20(b)(3) (1×) · 820.25(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
No management representative had been appointed to ensure that quality system requirements are met, and to…
- 02
Procedures for training and identifying training needs…
This inspection in context
Jude C. Dike
9 documents · 2015–2022
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Maryland.
The firmMaiden Biosciences history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.20(b)(3)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Maiden Biosciences?
FDA listed 2 observations on this Form 483, mostly about management controls. The most-cited regulation is 21 CFR 820.20 (management responsibility). The opening words of each observation are shown on this page.
Who inspected Maiden Biosciences?
Jude C. Dike is named on this Form 483, for the inspection of Nov 21 – Nov 28, 2022. Each investigator has a profile showing what they cite most.
When was Maiden Biosciences inspected by FDA?
The inspection ran Nov 21 – Nov 28, 2022, and the Form 483 is dated November 28, 2022.
How do I get the full Form 483 for Maiden Biosciences?
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.