Pharm D Solutions, LLC
Form 483 issued June 5, 2015 · Houston, Texas
- Inspection
- May 28 – Jun 5, 2015
- Investigator
- Stephen D. Brown
- Observations
- 8
- Pages
- 4
- FEI number
- 3011043554
In short: On June 5, 2015, FDA issued a Form 483 with 8 observations to Pharm D Solutions, LLC in Houston, Texas (FEI 3011043554) after an inspection that ran May 28 – Jun 5, 2015. The investigator was Stephen D. Brown. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Production and facilities & equipment account for 6 of 8 observations.
Most cited: 21 CFR 211.42 (3×) · 211.188 (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
Aseptic processing areas are deficient regarding the system…
- 03
Each batch of drug product purporting to be sterile is not laboratory tested to determine…
- 04
Aseptic 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 firmPharm D Solutions, LLC 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 Pharm D Solutions, LLC?
FDA listed 8 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. 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 Pharm D Solutions, LLC?
Stephen D. Brown is named on this Form 483, for the inspection of May 28 – Jun 5, 2015. Each investigator has a profile showing what they cite most.
When was Pharm D Solutions, LLC inspected by FDA?
The inspection ran May 28 – Jun 5, 2015, and the Form 483 is dated June 5, 2015.
How do I get the full Form 483 for Pharm D Solutions, 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.