Quality CDMO
FDA inspection history in Fort Worth, Texas, 2023 to 2024
- 1
- Warning letter
- 1
- Form 483
- 1
- Close-out
Every document, by year
- Warning letter
- Form 483
- Close-out
2023: one Form 483; 2024: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2023–24One Form 483 and one warning letter, at Fort Worth, Texas.
Cited most
Across all Quality CDMO observations on file
- 21 CFR 211.110(a)Sampling and testing of in-process materials and drug products1
- 21 CFR 211.111Time limitations on production1
- 21 CFR 211.22(a)Responsibilities of quality control unit1
The complete Quality CDMO file.
All 3 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
Fort Worth, Texas
One warning letter, one Form 483 and one close-out letter · 2023 to 2024 · 3 observations
Latest: Warning letter, Sep 11, 2024 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-09-11 | Warning letter Warning letter | Fort Worth, Texas | — | $99 |
| 2023-06-16 | 483 Form 483 | Fort Worth, Texas | 3 | $99 |
| Undated | Close-out Close-out letter | Fort Worth, Texas | — | $99 |
FEI number 3017569510 · most recent document Sep 11, 2024
About Quality CDMO
How many FDA Form 483s has Quality CDMO received?
FDA Intel has 1 Form 483 on file for Quality CDMO; the most recent is dated Jun 16, 2023.
When was Quality CDMO last inspected by FDA?
The most recent FDA inspection document on file for Quality CDMO is a Form 483 dated Jun 16, 2023, for the site in Fort Worth, Texas.
What did FDA cite at Quality CDMO?
The regulations cited most in the observations on file for Quality CDMO are 21 CFR 211.110(a) (Sampling and testing of in-process materials and drug products), 1 time; 21 CFR 211.111 (Time limitations on production), 1 time; 21 CFR 211.22(a) (Responsibilities of quality control unit), 1 time.
Has Quality CDMO received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Quality CDMO; the most recent is dated Sep 11, 2024.