Bausch & Lomb, Inc.
Form 483 issued February 25, 2016 · Tampa, Florida
- Inspection
- Feb 8 – Feb 25, 2016
- Investigators
- Denise M. Digiulio· Michael H. Tollon
- Observations
- 4
- Pages
- 8
- FEI number
- 1000113778
In short: On February 25, 2016, FDA issued a Form 483 with 4 observations to Bausch & Lomb, Inc. in Tampa, Florida (FEI 1000113778) after an inspection that ran Feb 8 – Feb 25, 2016. The investigators were Denise M. Digiulio and Michael H. Tollon. Most observations concern production and quality system.
At a glance
Production and quality system account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
Procedmes designed to prevent microbiological contrunination of dmg products pmp orting to be sterile are not…
- 03
Equipment and utensils ru·e not maintained at appropriate intervals to prevent contrunination that would alter the…
- 04
Control procedures are not established which monitor the output of those manufacturing processes that may be…
This inspection in context
Denise M. Digiulio
1 document · 2016
Cites 211.110 (sampling and testing of in-process materials and drug products) more than any other section. Most of their documents are for sites in Florida.
The firmBausch & Lomb, Inc. history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Bausch & Lomb, Inc.?
FDA listed 4 observations on this Form 483, mostly about production, quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Bausch & Lomb, Inc.?
Denise M. Digiulio and Michael H. Tollon are named on this Form 483, for the inspection of Feb 8 – Feb 25, 2016. Each investigator has a profile showing what they cite most.
When was Bausch & Lomb, Inc. inspected by FDA?
The inspection ran Feb 8 – Feb 25, 2016, and the Form 483 is dated February 25, 2016.
How do I get the full Form 483 for Bausch & Lomb, 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.