Unique Pharmaceutical, Ltd.
Form 483 issued December 8, 2016 · Temple, Texas
- Inspection
- Nov 28, 2016 – Dec 5, 2020
- Investigators
- Lisa R. Jennings· Stephen D. Brown
- Observations
- 4
- Pages
- 2
- FEI number
- 3002468086
In short: On December 8, 2016, FDA issued a Form 483 with 4 observations to Unique Pharmaceutical, Ltd. in Temple, Texas (FEI 3002468086) after an inspection that ran Nov 28, 2016 – Dec 5, 2020. The investigators were Lisa R. Jennings and Stephen D. Brown. Most observations concern facilities & equipment and packaging & labeling; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
3 of 4 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.42 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Observation 3: scanned text, readable in the full document.
- 04
The labels of your outsourcing facility's…
This inspection in context
Lisa R. Jennings
7 documents · 2014–2016
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 211.42
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 facilities & equipment and packaging & labeling. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Unique Pharmaceutical, Ltd.?
Lisa R. Jennings and Stephen D. Brown are named on this Form 483, for the inspection of Nov 28, 2016 – Dec 5, 2020. Each investigator has a profile showing what they cite most.
When was Unique Pharmaceutical, Ltd. inspected by FDA?
The inspection ran Nov 28, 2016 – Dec 5, 2020, and the Form 483 is dated December 8, 2016.
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.