Seatex LLC
FDA inspection history in Rosenberg, 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 Rosenberg, Texas.
Cited most
Across all Seatex 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 211.194(a)Laboratory records1
- 21 CFR 211.22(d)Responsibilities of quality control unit1
The complete Seatex 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
Rosenberg, Texas
One warning letter and one Form 483 · 2023 to 2024 · 6 observations
Latest: Warning letter, Apr 1, 2024 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-04-01 | Warning letter Warning letter | Rosenberg, Texas | — | $99 |
| 2023-10-20 | 483 Form 483 | Rosenberg, Texas | 6 | $99 |
Investigators on these documents
FEI number 3007709579 · most recent document Apr 1, 2024
About Seatex LLC
How many FDA Form 483s has Seatex LLC received?
FDA Intel has 1 Form 483 on file for Seatex LLC; the most recent is dated Oct 20, 2023.
When was Seatex LLC last inspected by FDA?
The most recent FDA inspection document on file for Seatex LLC is a Form 483 dated Oct 20, 2023, for the site in Rosenberg, Texas.
What did FDA cite at Seatex LLC?
The regulations cited most in the observations on file for Seatex LLC 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 Seatex LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Seatex LLC; the most recent is dated Apr 1, 2024.