Unique Pharmaceutical, Ltd.
Form 483 issued March 14, 2019 · Temple, Texas
- Inspection
- Feb 26 – Mar 14, 2019
- Investigators
- Aqualia L. Nelson· Margaret M. Annes
- Observations
- 9
- Pages
- 6
- FEI number
- 3002468086
In short: On March 14, 2019, FDA issued a Form 483 with 9 observations to Unique Pharmaceutical, Ltd. in Temple, Texas (FEI 3002468086) after an inspection that ran Feb 26 – Mar 14, 2019. The investigators were Aqualia L. Nelson and Margaret M. Annes. Most observations concern materials and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by materials.
Most cited: 21 CFR 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
Written procedures are lacking which describe in sufficient detail the receipt, identification…
- 02
There are no established written methods of cleaning or methods of processing…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
The separate or defined areas and control systems necessary to prevent contamination…
This inspection in context
Aqualia L. Nelson
1 document · 2019
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 9 observations on this Form 483, mostly about materials, facilities & equipment and production. 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.?
Aqualia L. Nelson and Margaret M. Annes are named on this Form 483, for the inspection of Feb 26 – Mar 14, 2019. Each investigator has a profile showing what they cite most.
When was Unique Pharmaceutical, Ltd. inspected by FDA?
The inspection ran Feb 26 – Mar 14, 2019, and the Form 483 is dated March 14, 2019.
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.