Bausch & Lomb Incorporated
Form 483 issued May 15, 2006 · Greenville, South Carolina
- Inspection
- Mar 22 – May 15, 2006
- Investigators
- Babatunde D. Babalola· Claudette D. Brooks
- Observations
- 18
- Pages
- 11
- FEI number
- 1032500
In short: On May 15, 2006, FDA issued a Form 483 with 18 observations to Bausch & Lomb Incorporated in Greenville, South Carolina (FEI 1032500) after an inspection that ran Mar 22 – May 15, 2006. The investigators were Babatunde D. Babalola and Claudette D. Brooks. Most observations concern production & process controls and design controls; the most-cited regulation is 21 CFR 820.70 (production and process controls).
At a glance
Production & process controls and design controls account for 10 of 16 observations.
Most cited: 21 CFR 820.70 (4×) · 820.30 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The-design does not describe the design and development activities, define responsibility for implementation of design dad…
- 02
Design input requirements that are…
- 03
Design reviews were not performed at appropriate times…
- 04
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of…
This inspection in context
Babatunde D. Babalola
2 documents · 2006–2015
Cites 820.70 (production and process controls) more than any other section. Most of their documents are for sites in North Carolina.
The firmBausch & Lomb Incorporated history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.70
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Bausch & Lomb Incorporated?
FDA listed 18 observations on this Form 483, mostly about production & process controls, design controls and cAPA. The most-cited regulation is 21 CFR 820.70 (production and process controls). The opening words of each observation are shown on this page.
Who inspected Bausch & Lomb Incorporated?
Babatunde D. Babalola and Claudette D. Brooks are named on this Form 483, for the inspection of Mar 22 – May 15, 2006. Each investigator has a profile showing what they cite most.
When was Bausch & Lomb Incorporated inspected by FDA?
The inspection ran Mar 22 – May 15, 2006, and the Form 483 is dated May 15, 2006.
How do I get the full Form 483 for Bausch & Lomb Incorporated?
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.