ARG Laboratories, Inc
FDA inspection history in Dallas, Texas, 2023 to 2024
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
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 Dallas, Texas.
Cited most
Across all ARG Laboratories observations on file
- 21 CFR 211.110(a)Sampling and testing of in-process materials and drug products1
- 21 CFR 211.137(a)Expiration dating1
- 21 CFR 211.160(b)General requirements1
- 21 CFR 211.165(f)Testing and release for distribution1
- 21 CFR 211.22(a)Responsibilities of quality control unit1
The complete ARG Laboratories file.
All 2 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
Dallas, Texas
One warning letter and one Form 483 · 2023 to 2024 · 7 observations
Latest: Warning letter, Jun 11, 2024 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-06-11 | Warning letter Warning letter | Dallas, Texas | — | $99 |
| 2023-09-20 | 483 Form 483 | Dallas, Texas | 7 | $99 |
Investigators on these documents
FEI number 3002556034 · most recent document Jun 11, 2024
About ARG Laboratories, Inc
How many FDA Form 483s has ARG Laboratories, Inc received?
FDA Intel has 1 Form 483 on file for ARG Laboratories, Inc; the most recent is dated Sep 20, 2023.
When was ARG Laboratories, Inc last inspected by FDA?
The most recent FDA inspection document on file for ARG Laboratories, Inc is a Form 483 dated Sep 20, 2023, for the site in Dallas, Texas.
What did FDA cite at ARG Laboratories, Inc?
The regulations cited most in the observations on file for ARG Laboratories, Inc are 21 CFR 211.110(a) (Sampling and testing of in-process materials and drug products), 1 time; 21 CFR 211.137(a) (Expiration dating), 1 time; 21 CFR 211.160(b) (General requirements), 1 time.
Has ARG Laboratories, Inc received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for ARG Laboratories, Inc; the most recent is dated Jun 11, 2024.