Century Pharmaceuticals, Inc.
Form 483 issued October 25, 2022 · Indianapolis, Indiana
- Inspection
- Oct 17 – Oct 25, 2022
- Investigator
- Sara M. Onyango
- Observations
- 7
- Pages
- 5
- FEI number
- 1819174
In short: On October 25, 2022, FDA issued a Form 483 with 7 observations to Century Pharmaceuticals, Inc. in Indianapolis, Indiana (FEI 1819174) after an inspection that ran Oct 17 – Oct 25, 2022. 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 5 of 7 observations.
Most cited: 21 CFR 820.30(g) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Risk analysis is…
- 02
Procedures for design change have…
- 03
Procedures for design validation have…
- 04
A process whose results cannot be fully verified by subsequent inspection and test has not been…
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 firmCentury Pharmaceuticals, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.30(g)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Century Pharmaceuticals, Inc.?
FDA listed 7 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 Century Pharmaceuticals, Inc.?
Sara M. Onyango is named on this Form 483, for the inspection of Oct 17 – Oct 25, 2022. Each investigator has a profile showing what they cite most.
When was Century Pharmaceuticals, Inc. inspected by FDA?
The inspection ran Oct 17 – Oct 25, 2022, and the Form 483 is dated October 25, 2022.
How do I get the full Form 483 for Century Pharmaceuticals, 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.