Ben Venue Laboratories, Inc.
Form 483 issued May 25, 2011 · Bedford, Ohio
- Inspection
- May 2 – May 25, 2011
- Investigators
- Paul A. Bennvagu· Sneha J. Padey
- Observations
- 7
- Pages
- 33
- FEI number
- 1519257
In short: On May 25, 2011, FDA issued a Form 483 with 7 observations to Ben Venue Laboratories, Inc. in Bedford, Ohio (FEI 1519257) after an inspection that ran May 2 – May 25, 2011. The investigators were Paul A. Bennvagu and Sneha J. Padey. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and quality system account for 6 of 7 observations.
Most cited: 21 CFR 211.113 (4×)
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
Failure to identify the root cause of foreign material, identified as stainless steel particles in two…
- 03
The "Media Fill Program Parameters and Specifications" document #030-SOP-029, and the "Outlining Test Parameters and Specifications…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Paul A. Bennvagu
1 document · 2011
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Ohio.
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 7 observations on this Form 483, mostly about production, quality system 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 Ben Venue Laboratories, Inc.?
Paul A. Bennvagu and Sneha J. Padey are named on this Form 483, for the inspection of May 2 – May 25, 2011. Each investigator has a profile showing what they cite most.
When was Ben Venue Laboratories, Inc. inspected by FDA?
The inspection ran May 2 – May 25, 2011, and the Form 483 is dated May 25, 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.