INCELL Corporation LLC
Form 483 issued September 1, 2015 · San Antonio, Texas
- Inspection
- Aug 18 – Sep 1, 2015
- Investigator
- Patrice S. Hall
- Observations
- 4
- Pages
- 4
- FEI number
- 3004107906
In short: On September 1, 2015, FDA issued a Form 483 with 4 observations to INCELL Corporation LLC in San Antonio, Texas (FEI 3004107906) after an inspection that ran Aug 18 – Sep 1, 2015. The investigator was Patrice S. Hall. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding the system…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established…
- 03
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 04FDCA 503B(a)(10)
The container labels of your outsourcing facility?s…
This inspection in context
Patrice S. Hall
7 documents · 2014–2016
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Texas.
The firmINCELL Corporation LLC history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42(c)(10)(iv)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at INCELL Corporation LLC?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment and production. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected INCELL Corporation LLC?
Patrice S. Hall is named on this Form 483, for the inspection of Aug 18 – Sep 1, 2015. Each investigator has a profile showing what they cite most.
When was INCELL Corporation LLC inspected by FDA?
The inspection ran Aug 18 – Sep 1, 2015, and the Form 483 is dated September 1, 2015.
How do I get the full Form 483 for INCELL Corporation LLC?
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.