Unique Pharmaceutical, Ltd.
Form 483 issued April 20, 2018 · Temple, Texas
- Inspection
- Apr 16 – Apr 20, 2018
- Investigator
- Scott Ballard
- Observations
- 4
- Pages
- 3
- FEI number
- 3002468086
In short: On April 20, 2018, FDA issued a Form 483 with 4 observations to Unique Pharmaceutical, Ltd. in Temple, Texas (FEI 3002468086) after an inspection that ran Apr 16 – Apr 20, 2018. The investigator was Scott Ballard. Most observations concern quality system and production.
At a glance
Quality system and production account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
Written records of investigation of a drng complaint do not include the findings of the investigation…
- 03
There are no written procedures for production and process con trols designed to assure that the…
- 04
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to as…
This inspection in context
Scott Ballard
30 documents · 2011–2025
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Texas.
The firmUnique Pharmaceutical, Ltd. history
All 9 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Unique Pharmaceutical, Ltd.?
FDA listed 4 observations on this Form 483, mostly about quality system, production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Unique Pharmaceutical, Ltd.?
Scott Ballard is named on this Form 483, for the inspection of Apr 16 – Apr 20, 2018. Each investigator has a profile showing what they cite most.
When was Unique Pharmaceutical, Ltd. inspected by FDA?
The inspection ran Apr 16 – Apr 20, 2018, and the Form 483 is dated April 20, 2018.
How do I get the full Form 483 for Unique Pharmaceutical, Ltd.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.