INCELL Corporation LLC
FDA inspection history in San Antonio, Texas, 2015 to 2024
- 2
- Close-outs
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Close-out
- Form 483
2015: one Form 483; 2016: one close-out letter; 2019: one close-out letter; 2024: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2015–16One Form 483 and one close-out letter, at San Antonio, Texas.
- 2019One close-out letter, at San Antonio, Texas.
- 2024One warning letter, at San Antonio, Texas.
Cited most
Across all INCELL Corporation observations on file
- 21 CFR 211.42(c)(10)(iv)Design and construction features2
- 21 CFR 211.113(b)Control of microbiological contamination1
- FDCA 503B(a)(10)1
The complete INCELL Corporation file.
All 4 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
San Antonio, Texas
Two close-out letters, one warning letter and one Form 483 · 2015 to 2024 · 4 observations
Latest: Warning letter, Dec 12, 2024 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-12-12 | Warning letter Warning letter | San Antonio, Texas | — | $99 |
| 2019-05-24 | Close-out Close-out letter | San Antonio, Texas | — | $99 |
| 2016-10-28 | Close-out Close-out letter | San Antonio, Texas | — | $99 |
| 2015-09-01 | 483 Form 483 | San Antonio, Texas | 4 | $99 |
Investigators on these documents
FEI number 3004107906 · most recent document Dec 12, 2024
About INCELL Corporation LLC
How many FDA Form 483s has INCELL Corporation LLC received?
FDA Intel has 1 Form 483 on file for INCELL Corporation LLC; the most recent is dated Sep 1, 2015.
When was INCELL Corporation LLC last inspected by FDA?
The most recent FDA inspection document on file for INCELL Corporation LLC is a Form 483 dated Sep 1, 2015, for the site in San Antonio, Texas.
What did FDA cite at INCELL Corporation LLC?
The regulations cited most in the observations on file for INCELL Corporation LLC are 21 CFR 211.42(c)(10)(iv) (Design and construction features), 2 times; 21 CFR 211.113(b) (Control of microbiological contamination), 1 time; FDCA 503B(a)(10), 1 time.
Has INCELL Corporation LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for INCELL Corporation LLC; the most recent is dated Dec 12, 2024.