Mannkind Corporation
Form 483 issued August 6, 2021 · Danbury, Connecticut
- Inspection
- Jul 27 – Aug 6, 2021
- Observations
- 1
- Pages
- 4
- FEI number
- 3005340341
In short: On August 6, 2021, FDA issued a Form 483 with 1 observation to Mannkind Corporation in Danbury, Connecticut (FEI 3005340341) after an inspection that ran Jul 27 – Aug 6, 2021. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.68 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Routine inspection and checking of automatic and mechanical equipment is not performed according to a written…
This inspection in context
Questions about this 483
What did FDA find at Mannkind Corporation?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
When was Mannkind Corporation inspected by FDA?
The inspection ran Jul 27 – Aug 6, 2021, and the Form 483 is dated August 6, 2021.
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.