CellTrans Inc.
Form 483 issued June 11, 2021 · Chicago, Illinois
- Inspection
- Jun 7 – Jun 11, 2021
- Observations
- 12
- Pages
- 6
- FEI number
- 3019202665
In short: On June 11, 2021, FDA issued a Form 483 with 12 observations to CellTrans Inc. in Chicago, Illinois (FEI 3019202665) after an inspection that ran Jun 7 – Jun 11, 2021. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Observations span 4 systems, led by facilities & equipment.
Most cited: 21 CFR 211.113 (3×) · 211.22 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm’s Quality Unit lacks a procedure/policy that details requirements for the following: An (b) (4)…
- 02
The current deviation reporting…
- 03
Final product lots were released with incomplete batch record or failed lot release specifications. The batch…
- 04
Regarding your firm's current aseptic process observed during inspection we…
This inspection in context
Questions about this 483
What did FDA find at CellTrans Inc.?
FDA listed 12 observations on this Form 483, mostly about facilities & equipment, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
When was CellTrans Inc. inspected by FDA?
The inspection ran Jun 7 – Jun 11, 2021, and the Form 483 is dated June 11, 2021.
How do I get the full Form 483 for CellTrans 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.