Unique Pharmaceutical, Ltd.
FDA inspection history in Temple, Texas, 2014 to 2022
- 7
- Form 483s
- 1
- Close-out
Every document, by year
- Form 483
- Close-out
2014: two Form 483s and one fda_correspondence; 2015: one close-out letter and one Form 483; 2016: one Form 483; 2018: one Form 483; 2019: one Form 483; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2014–19Six Form 483s, one fda_correspondence and one close-out letter, at Temple, Texas.
- 2014The longest 483 on file: 10 observations over 7 pages at Temple, Texas.
- 2022One Form 483, at Temple, Texas.
Cited most
Across all Unique Pharmaceutical observations on file
- 21 CFR 211.42Design and construction features16
- 21 CFR 211.192Production record review5
- 21 CFR 211.113Control of microbiological contamination4
- 21 CFR 211.28Personnel responsibilities2
- 21 CFR 211.94Drug product containers and closures2
The complete Unique Pharmaceutical file.
All 8 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Temple, Texas
Seven Form 483s, one close-out letter and one fda_correspondence · 2014 to 2022 · 42 observations
Latest: Form 483, Jun 16, 2022 →
Documents
9 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-06-16 | 483 Form 483 | Temple, Texas | 4 | $99 |
| 2019-03-14 | 483 Form 483 | Temple, Texas | 9 | $99 |
| 2018-04-20 | 483 Form 483 | Temple, Texas | 4 | $99 |
| 2016-12-08 | 483 Form 483 | Temple, Texas | 4 | $99 |
| 2015-12-11 | Close-out Close-out letter | Temple, Texas | — | $99 |
| 2015-01-23 | 483 Form 483 | Temple, Texas | 6 | $99 |
| 2014-06-20 | fda_correspondence FDA document | Temple, Texas | — | — |
| 2014-06-20 | 483 Form 483 | Temple, Texas | 5 | $99 |
| 2014-04-02 | 483 Form 483 | Temple, Texas | 10 | $99 |
Investigators on these documents
Scott Ballard (2)Stephen D. Brown (2)Aqualia L. Nelson (1)Camerson E. Moore (1)Damaris Y. Hernandez (1)Ademola O. Daramola (1)Lisa R. Jennings (1)Margaret M. Annes (1)Patrice S. Hall (1)J. Christopher (1)Andrea A. Branche (1)
FEI number 3002468086 · most recent document Jun 16, 2022
About Unique Pharmaceutical, Ltd.
How many FDA Form 483s has Unique Pharmaceutical, Ltd. received?
FDA Intel has 7 Form 483s on file for Unique Pharmaceutical, Ltd.; the most recent is dated Jun 16, 2022.
When was Unique Pharmaceutical, Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Unique Pharmaceutical, Ltd. is a Form 483 dated Jun 16, 2022, for the site in Temple, Texas.
What did FDA cite at Unique Pharmaceutical, Ltd.?
The regulations cited most in the observations on file for Unique Pharmaceutical, Ltd. are 21 CFR 211.42 (Design and construction features), 16 times; 21 CFR 211.192 (Production record review), 5 times; 21 CFR 211.113 (Control of microbiological contamination), 4 times.