Pharma Nobis, LLC
Form 483 issued July 1, 2015 · Texarkana, Texas
- Inspection
- Jun 25 – Jul 1, 2015
- Investigators
- Carlos Chavez· Yasamin Ameri· Yumi J. Hiramine
- Observations
- 11
- Pages
- 5
- FEI number
- 1611206
In short: On July 1, 2015, FDA issued a Form 483 with 11 observations to Pharma Nobis, LLC in Texarkana, Texas (FEI 1611206) after an inspection that ran Jun 25 – Jul 1, 2015. The investigators were Carlos Chavez, Yasamin Ameri and Yumi J. Hiramine. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and quality system account for 8 of 11 observations.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observation- 01
There are no written procedures for production and process controls designed to assure that the drug…
- 02
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 03
Procedures for the cleaning and maintenance of equipment are deficient regarding maintenance and cleaning schedules, including…
- 04
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
This inspection in context
Carlos Chavez
2 documents · 2015
Cites 211.67(b) (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in Texas.
The firmPharma Nobis, LLC history
All 2 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 Pharma Nobis, LLC?
FDA listed 11 observations on this Form 483, mostly about facilities & equipment, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Pharma Nobis, LLC?
Carlos Chavez, Yasamin Ameri and Yumi J. Hiramine are named on this Form 483, for the inspection of Jun 25 – Jul 1, 2015. Each investigator has a profile showing what they cite most.
When was Pharma Nobis, LLC inspected by FDA?
The inspection ran Jun 25 – Jul 1, 2015, and the Form 483 is dated July 1, 2015.
How do I get the full Form 483 for Pharma Nobis, LLC?
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.