Mannkind Corporation
Form 483 issued October 3, 2024 · Marlborough, Massachusetts
- Inspection
- Sep 19 – Oct 3, 2024
- Investigator
- Sara M. Onyango
- Observations
- 5
- Pages
- 6
- FEI number
- 3003154078
In short: On October 3, 2024, FDA issued a Form 483 with 5 observations to Mannkind Corporation in Marlborough, Massachusetts (FEI 3003154078) after an inspection that ran Sep 19 – Oct 3, 2024. The investigator was Sara M. Onyango. Most observations concern design controls and cAPA; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
Design controls and capa account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
Sampling plans are not based…
- 02
Procedures for design change have…
- 03
Design validation did not ensure the device conforms to defined user…
- 04
Procedures for corrective and preventive action have…
This inspection in context
Sara M. Onyango
9 documents · 2019–2026
Cites 820.30(f) (design controls) more than any other section. Most of their documents are for sites in Massachusetts.
The firmMannkind Corporation history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.250(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Mannkind Corporation?
FDA listed 5 observations on this Form 483, mostly about design controls, cAPA and production & process controls. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Mannkind Corporation?
Sara M. Onyango is named on this Form 483, for the inspection of Sep 19 – Oct 3, 2024. Each investigator has a profile showing what they cite most.
When was Mannkind Corporation inspected by FDA?
The inspection ran Sep 19 – Oct 3, 2024, and the Form 483 is dated October 3, 2024.
How do I get the full Form 483 for Mannkind Corporation?
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.