Advanced Pharma, Inc.
Form 483 issued July 22, 2016 · Houston, Texas
- Inspection
- Jul 11 – Jul 22, 2016
- Investigator
- Stephen D. Brown
- Observations
- 5
- Pages
- 4
- FEI number
- 3005247494
In short: On July 22, 2016, FDA issued a Form 483 with 5 observations to Advanced Pharma, Inc. in Houston, Texas (FEI 3005247494) after an inspection that ran Jul 11 – Jul 22, 2016. The investigator was Stephen D. Brown. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
3 of 5 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 02
Test procedures relative to appropriate laboratory testing for sterility and…
- 03
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 04
Procedures describing the calibration of instruments, apparatus, gauges and recording devices are…
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 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Advanced Pharma, Inc.?
FDA listed 5 observations on this Form 483, mostly about laboratory controls, production and packaging & labeling. The most-cited regulation is 21 CFR 211.160 (general requirements). 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 Jul 11 – Jul 22, 2016. Each investigator has a profile showing what they cite most.
When was Advanced Pharma, Inc. inspected by FDA?
The inspection ran Jul 11 – Jul 22, 2016, and the Form 483 is dated July 22, 2016.
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.