Unique Pharmaceutical, Ltd.
Form 483 issued June 20, 2014 · Temple, Texas
- Inspection
- Jun 9 – Jun 20, 2014
- Investigators
- Andrea A. Branche· Scott Ballard
- Observations
- 5
- Pages
- 4
- FEI number
- 3002468086
In short: On June 20, 2014, FDA issued a Form 483 with 5 observations to Unique Pharmaceutical, Ltd. in Temple, Texas (FEI 3002468086) after an inspection that ran Jun 9 – Jun 20, 2014. The investigators were Andrea A. Branche and Scott Ballard. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and facilities & equipment account for 4 of 5 observations.
Most cited: 21 CFR 211.192 (2×) · 211.42 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review the failure of a batch or any of its…
- 02
Production errors are not…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 04
separate or defined areas necessary to prevent contamination…
This inspection in context
Andrea A. Branche
6 documents · 2009–2018
Cites 56.108(a)(1) (irb functions and operations) 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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Unique Pharmaceutical, Ltd.?
FDA listed 5 observations on this Form 483, mostly about quality system, facilities & equipment and production. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Unique Pharmaceutical, Ltd.?
Andrea A. Branche and Scott Ballard are named on this Form 483, for the inspection of Jun 9 – Jun 20, 2014. Each investigator has a profile showing what they cite most.
When was Unique Pharmaceutical, Ltd. inspected by FDA?
The inspection ran Jun 9 – Jun 20, 2014, and the Form 483 is dated June 20, 2014.
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.