Delsam Pharma LLC
FDA inspection history across 2 sites, 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 Bronx, New York and Mamaroneck, New York.
Cited most
Across all Delsam Pharma observations on file
- 21 CFR 211.142(b)Warehousing procedures1
- 21 CFR 211.150(b)Distribution procedures1
- 21 CFR 211.180(e)(2)General requirements1
- 21 CFR 211.198(a)Complaint files1
- 21 CFR 211.22(a)Responsibilities of quality control unit1
The complete Delsam Pharma 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
Mamaroneck, New York
One warning letter · 2024
Latest: Warning letter, Feb 13, 2024 →Bronx, New York
One Form 483 · 2023 · 5 observations
Latest: Form 483, Mar 24, 2023 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-02-13 | Warning letter Warning letter | Mamaroneck, New York | — | $99 |
| 2023-03-24 | 483 Form 483 | Bronx, New York | 5 | $99 |
Investigators on these documents
FEI number 3018035065 · most recent document Feb 13, 2024
About Delsam Pharma LLC
How many FDA Form 483s has Delsam Pharma LLC received?
FDA Intel has 1 Form 483 on file for Delsam Pharma LLC; the most recent is dated Mar 24, 2023.
When was Delsam Pharma LLC last inspected by FDA?
The most recent FDA inspection document on file for Delsam Pharma LLC is a Form 483 dated Mar 24, 2023, for the site in Bronx, New York.
What did FDA cite at Delsam Pharma LLC?
The regulations cited most in the observations on file for Delsam Pharma LLC are 21 CFR 211.142(b) (Warehousing procedures), 1 time; 21 CFR 211.150(b) (Distribution procedures), 1 time; 21 CFR 211.180(e)(2) (General requirements), 1 time.
Has Delsam Pharma LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Delsam Pharma LLC; the most recent is dated Feb 13, 2024.