Topway Enterprises
Form 483 issued February 8, 2019 · Houston, Texas
- Inspection
- Feb 4 – Feb 8, 2019
- Investigators
- Charles B. Steinmiller· Christopher J. Hurst· Lakesha D. Debardelaben
- Observations
- 3
- Pages
- 4
- FEI number
- 3000204829
In short: On February 8, 2019, FDA issued a Form 483 with 3 observations to Topway Enterprises in Houston, Texas (FEI 3000204829) after an inspection that ran Feb 4 – Feb 8, 2019. The investigators were Charles B. Steinmiller, Christopher J. Hurst and Lakesha D. Debardelaben. Most observations concern food CGMP / preventive controls; the most-cited regulation is 21 CFR 123.11 (sanitation control procedures).
At a glance
Observations span 1 system, led by food cgmp / preventive controls.
Most cited: 21 CFR 123.11(b) (2×) · 110.20(b)(4) (1×)
What FDA observed
Preview: the opening words of each observation- 01
You are not monitoring the sanitation conditions and practices with sufficient frequency to assure conformance with…
- 02
Your sanitation control records do not accurately document the conditions or practices…
- 03
The plant is not constmcted in such a manner as to allow floors to be adequately…
This inspection in context
Charles B. Steinmiller
5 documents · 2015–2024
Cites 110.35 (sanitary operations) more than any other section. Most of their documents are for sites in Texas.
The firmTopway Enterprises history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 123.11(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Topway Enterprises?
FDA listed 3 observations on this Form 483, mostly about food CGMP / preventive controls. The most-cited regulation is 21 CFR 123.11 (sanitation control procedures). The opening words of each observation are shown on this page.
Who inspected Topway Enterprises?
Charles B. Steinmiller, Christopher J. Hurst and Lakesha D. Debardelaben are named on this Form 483, for the inspection of Feb 4 – Feb 8, 2019. Each investigator has a profile showing what they cite most.
When was Topway Enterprises inspected by FDA?
The inspection ran Feb 4 – Feb 8, 2019, and the Form 483 is dated February 8, 2019.
How do I get the full Form 483 for Topway Enterprises?
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