Total Vein Pharmacy LLC dba Total Vein Pharmacy
Form 483 issued May 9, 2019 · Houston, Texas
- Inspection
- Mar 11 – May 9, 2019
- Investigator
- Stephen D. Brown
- Observations
- 3
- Pages
- 1
- FEI number
- 3014613445
In short: On May 9, 2019, FDA issued a Form 483 with 3 observations to Total Vein Pharmacy LLC dba Total Vein Pharmacy in Houston, Texas (FEI 3014613445) after an inspection that ran Mar 11 – May 9, 2019. The investigator was Stephen D. Brown. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
2 of 3 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (2×) · 211.42 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The ISO 5 classified areas were not…
- 02
Media fills were not performed that closely simulate aseptic production operations incorporating, as appropriate, worst case…
- 03
Your firm uses the following disinfectants in the ISO 5 area, (b)(4) Cleaner and (b)(4). The…
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 firmTotal Vein Pharmacy LLC dba Total Vein Pharmacy history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Total Vein Pharmacy LLC dba Total Vein Pharmacy?
FDA listed 3 observations on this Form 483, mostly about production and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Total Vein Pharmacy LLC dba Total Vein Pharmacy?
Stephen D. Brown is named on this Form 483, for the inspection of Mar 11 – May 9, 2019. Each investigator has a profile showing what they cite most.
When was Total Vein Pharmacy LLC dba Total Vein Pharmacy inspected by FDA?
The inspection ran Mar 11 – May 9, 2019, and the Form 483 is dated May 9, 2019.
How do I get the full Form 483 for Total Vein Pharmacy LLC dba Total Vein Pharmacy?
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.