Advanced Pharma, Inc.
Form 483 issued March 17, 2014 · Houston, Texas
- Inspection
- Mar 3 – Mar 17, 2014
- Investigator
- Stephen D. Brown
- Observations
- 6
- Pages
- 3
- FEI number
- 3005247494
In short: On March 17, 2014, FDA issued a Form 483 with 6 observations to Advanced Pharma, Inc. in Houston, Texas (FEI 3005247494) after an inspection that ran Mar 3 – Mar 17, 2014. The investigator was Stephen D. Brown. Most observations concern facilities & equipment and production.
At a glance
Observations span 3 systems, led by facilities & equipment.
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…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to…
- 03
of personnel engaged in the processing of drug products is not appropriate for…
- 04
processing areas are deficient regarding systems for maintaining any equipment used to…
This inspection in context
Stephen D. Brown
42 documents · 2006–2021
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
The firmAdvanced Pharma, Inc. history
All 3 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 Advanced Pharma, Inc.?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Advanced Pharma, Inc.?
Stephen D. Brown is named on this Form 483, for the inspection of Mar 3 – Mar 17, 2014. Each investigator has a profile showing what they cite most.
When was Advanced Pharma, Inc. inspected by FDA?
The inspection ran Mar 3 – Mar 17, 2014, and the Form 483 is dated March 17, 2014.
How do I get the full Form 483 for Advanced Pharma, Inc.?
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.