Unique Pharmaceutical, Ltd.
Form 483 issued June 16, 2022 · Temple, Texas
- Inspection
- Jun 7 – Jun 16, 2022
- Investigators
- Camerson E. Moore· Damaris Y. Hernandez
- Observations
- 4
- Pages
- 4
- FEI number
- 3002468086
In short: On June 16, 2022, FDA issued a Form 483 with 4 observations to Unique Pharmaceutical, Ltd. in Temple, Texas (FEI 3002468086) after an inspection that ran Jun 7 – Jun 16, 2022. The investigators were Camerson E. Moore and Damaris Y. Hernandez. Most observations concern facilities & equipment and production.
At a glance
Facilities & equipment and production account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient in that floors are not smooth and/or hard surfaces…
- 02
Input to and output from the computer and records or data are…
- 03
The master production and control records are deficient in that they do not include complete…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Camerson E. Moore
48 documents · 2014–2026
Cites 211.113 (control of microbiological contamination) 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(c)(10)(i)
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, production and packaging & labeling. The opening words of each observation are shown on this page.
Who inspected Unique Pharmaceutical, Ltd.?
Camerson E. Moore and Damaris Y. Hernandez are named on this Form 483, for the inspection of Jun 7 – Jun 16, 2022. Each investigator has a profile showing what they cite most.
When was Unique Pharmaceutical, Ltd. inspected by FDA?
The inspection ran Jun 7 – Jun 16, 2022, and the Form 483 is dated June 16, 2022.
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.