Sovereign Pharmaceuticals, LLC
FDA inspection history in Fort Worth, Texas, 2013 to 2023
- 6
- Form 483s
- 2
- Warning letters
- 1
- Close-out
Every document, by year
- Form 483
- Warning letter
- Close-out
2013: one warning letter; 2015: one Form 483; 2018: one Form 483; 2019: one Form 483 and one close-out letter; 2021: one Form 483; 2022: one warning letter and one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2013–15One warning letter and one Form 483, at Fort Worth, Texas.
- 2018–23Five Form 483s, one close-out letter and one warning letter, at Fort Worth, Texas.
- 2022The longest 483 on file: 4 observations over 6 pages at Fort Worth, Texas.
Cited most
Across all Sovereign Pharmaceuticals observations on file
- 21 CFR 211.22Responsibilities of quality control unit5
- 21 CFR 211.160General requirements3
- 21 CFR 211.100(a)Written procedures; deviations1
- 21 CFR 211.166Stability testing1
- 21 CFR 211.186(b)(9)Master production and control records1
The complete Sovereign Pharmaceuticals file.
All 9 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Fort Worth, Texas
Six Form 483s, two warning letters and one close-out letter · 2013 to 2023 · 18 observations
Latest: Form 483, Aug 2, 2023 →
Documents
9 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-08-02 | 483 Form 483 | Fort Worth, Texas | 3 | $99 |
| 2022-10-05 | Warning letter Warning letter | Fort Worth, Texas | — | $99 |
| 2022-04-22 | 483 Form 483 | Fort Worth, Texas | 4 | $99 |
| 2021-09-01 | 483 Form 483 | Fort Worth, Texas | 3 | $99 |
| 2019-12-12 | 483 Form 483 | Fort Worth, Texas | 3 | $99 |
| 2019-06-04 | Close-out Close-out letter | Fort Worth, Texas | — | $99 |
| 2018-01-12 | 483 Form 483 | Fort Worth, Texas | 2 | $99 |
| 2015-08-21 | 483 Form 483 | Fort Worth, Texas | 3 | $99 |
| 2013-01-29 | Warning letter Warning letter | Fort Worth, Texas | — | $99 |
Investigators on these documents
Patty P. Kaewussdangkul (3)Adaris Mas Rivera (1)Christopher N. Tran (1)A. Ol (1)Scott Ballard (1)Unnee Ranjan (1)Matthew R. Maddox (1)
FEI number 3003229412 · most recent document Aug 2, 2023
About Sovereign Pharmaceuticals, LLC
How many FDA Form 483s has Sovereign Pharmaceuticals, LLC received?
FDA Intel has 6 Form 483s on file for Sovereign Pharmaceuticals, LLC; the most recent is dated Aug 2, 2023.
When was Sovereign Pharmaceuticals, LLC last inspected by FDA?
The most recent FDA inspection document on file for Sovereign Pharmaceuticals, LLC is a Form 483 dated Aug 2, 2023, for the site in Fort Worth, Texas.
What did FDA cite at Sovereign Pharmaceuticals, LLC?
The regulations cited most in the observations on file for Sovereign Pharmaceuticals, LLC are 21 CFR 211.22 (Responsibilities of quality control unit), 5 times; 21 CFR 211.160 (General requirements), 3 times; 21 CFR 211.100(a) (Written procedures; deviations), 1 time.
Has Sovereign Pharmaceuticals, LLC received an FDA warning letter?
Yes. FDA Intel has 2 FDA warning letters on file for Sovereign Pharmaceuticals, LLC; the most recent is dated Oct 5, 2022.