13 PHARMACEUTICALS LLC
FDA inspection history in Warminster, Pennsylvania, 2018 to 2023
- 3
- Form 483s
Every document, by year
- Form 483
2018: one Form 483; 2022: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2018One Form 483, at Warminster, Pennsylvania.
- 2022–23Two Form 483s, at Warminster, Pennsylvania.
- 2022The longest 483 on file: 5 observations over 8 pages at Warminster, Pennsylvania.
Cited most
Across all 13 PHARMACEUTICALS observations on file
- 21 CFR 211.67Equipment cleaning and maintenance3
- 21 CFR 211.160General requirements2
- 21 CFR 211.142Warehousing procedures1
- 21 CFR 211.192Production record review1
- 21 CFR 211.22Responsibilities of quality control unit1
The complete 13 PHARMACEUTICALS 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
Warminster, Pennsylvania
Three Form 483s · 2018 to 2023 · 11 observations
Latest: Form 483, Mar 3, 2023 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-03-03 | 483 Form 483 | Warminster, Pennsylvania | 2 | $99 |
| 2022-02-22 | 483 Form 483 | Warminster, Pennsylvania | 5 | $99 |
| 2018-12-21 | 483 Form 483 | Warminster, Pennsylvania | 4 | $99 |
Investigators on these documents
Daniel J. Min (2)David A. Oluwo (1)Janet A. Rajan (1)Junho Pak (1)
FEI number 3012763653 · most recent document Mar 3, 2023
About 13 PHARMACEUTICALS LLC
How many FDA Form 483s has 13 PHARMACEUTICALS LLC received?
FDA Intel has 3 Form 483s on file for 13 PHARMACEUTICALS LLC; the most recent is dated Mar 3, 2023.
When was 13 PHARMACEUTICALS LLC last inspected by FDA?
The most recent FDA inspection document on file for 13 PHARMACEUTICALS LLC is a Form 483 dated Mar 3, 2023, for the site in Warminster, Pennsylvania.
What did FDA cite at 13 PHARMACEUTICALS LLC?
The regulations cited most in the observations on file for 13 PHARMACEUTICALS LLC are 21 CFR 211.67 (Equipment cleaning and maintenance), 3 times; 21 CFR 211.160 (General requirements), 2 times; 21 CFR 211.142 (Warehousing procedures), 1 time.