Ben Venue Laboratories, Inc.
Form 483 issued December 2, 2011 · Bedford, Ohio
- Inspection
- Nov 7 – Dec 2, 2011
- Investigators
- Christopher T. Middendorf· Dell S. Moller· Dells Moller
- Observations
- 10
- Pages
- 12
- FEI number
- 1519257
In short: On December 2, 2011, FDA issued a Form 483 with 10 observations to Ben Venue Laboratories, Inc. in Bedford, Ohio (FEI 1519257) after an inspection that ran Nov 7 – Dec 2, 2011. The investigators were Christopher T. Middendorf, Dell S. Moller, Dells Moller, Michael P. Sheehan and Thomas J. Arista. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Observations span 1 system, led by production.
Most cited: 21 CFR 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The "Quality Manual", document #030-SOP-OP-01340, dated 28 Feb 2011, "describes the pharmaceutical quality system (PQS) as…
- 02
The "Media Fill Program Parameters and Specifications" document #030-SOP-D-29, dated 19 Aug 2011 defines media fill…
This inspection in context
Christopher T. Middendorf
8 documents · 2011–2020
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in China.
The firmBen Venue Laboratories, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
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 Ben Venue Laboratories, Inc.?
FDA listed 10 observations on this Form 483, mostly about production. 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 Ben Venue Laboratories, Inc.?
Christopher T. Middendorf, Dell S. Moller, Dells Moller, Michael P. Sheehan and Thomas J. Arista are named on this Form 483, for the inspection of Nov 7 – Dec 2, 2011. Each investigator has a profile showing what they cite most.
When was Ben Venue Laboratories, Inc. inspected by FDA?
The inspection ran Nov 7 – Dec 2, 2011, and the Form 483 is dated December 2, 2011.
How do I get the full Form 483 for Ben Venue Laboratories, 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.