Bhaumik Diversified LLC dba Texas St ar
Form 483 issued November 3, 2021 · Plano, Texas
- Inspection
- Oct 19 – Nov 3, 2021
- Investigator
- Patty P. Kaewussdangkul
- Observations
- 12
- Pages
- 8
- FEI number
- 3012032875
In short: On November 3, 2021, FDA issued a Form 483 with 12 observations to Bhaumik Diversified LLC dba Texas St ar in Plano, Texas (FEI 3012032875) after an inspection that ran Oct 19 – Nov 3, 2021. The investigator was Patty P. Kaewussdangkul. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and facilities & equipment account for 11 of 12 observations.
Most cited: 21 CFR 211.113 (7×) · 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
You produced hazardous and potent drugs w ithout providing adequat e segregation and cleaning of…
- 02
Smoke studies performed under dynamic…
- 03
EMPLOYEE($) SIGNATURE Products Failure to conduct media fills that closely simulates aseptic production operations under the…
- 04
Disinfectant contact time (also known as "dwell ti me") and coverage of the item being disinfected…
This inspection in context
Patty P. Kaewussdangkul
54 documents · 2006–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
The firmBhaumik Diversified LLC dba Texas St ar 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 Bhaumik Diversified LLC dba Texas St ar?
FDA listed 12 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 Bhaumik Diversified LLC dba Texas St ar?
Patty P. Kaewussdangkul is named on this Form 483, for the inspection of Oct 19 – Nov 3, 2021. Each investigator has a profile showing what they cite most.
When was Bhaumik Diversified LLC dba Texas St ar inspected by FDA?
The inspection ran Oct 19 – Nov 3, 2021, and the Form 483 is dated November 3, 2021.
How do I get the full Form 483 for Bhaumik Diversified LLC dba Texas St ar?
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.