Unique Pharmaceutical, Ltd.
Form 483 issued January 23, 2015 · Temple, Texas
- Inspection
- Jan 13 – Jan 23, 2015
- Investigators
- Ademola O. Daramola· Patrice S. Hall· Stephen D. Brown
- Observations
- 6
- Pages
- 3
- FEI number
- 3002468086
In short: On January 23, 2015, FDA issued a Form 483 with 6 observations to Unique Pharmaceutical, Ltd. in Temple, Texas (FEI 3002468086) after an inspection that ran Jan 13 – Jan 23, 2015. The investigators were Ademola O. Daramola, Patrice S. Hall and Stephen D. Brown. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
4 of 6 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 04
Written records of investigations into unexplained discrepancies do not include…
This inspection in context
Ademola O. Daramola
11 documents · 2014–2018
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 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Unique Pharmaceutical, Ltd.?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment, production and quality system. 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.?
Ademola O. Daramola, Patrice S. Hall and Stephen D. Brown are named on this Form 483, for the inspection of Jan 13 – Jan 23, 2015. Each investigator has a profile showing what they cite most.
When was Unique Pharmaceutical, Ltd. inspected by FDA?
The inspection ran Jan 13 – Jan 23, 2015, and the Form 483 is dated January 23, 2015.
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.