Bausch & Lomb, Incorporated
Form 483 issued July 13, 2018 · Lynchburg, Virginia
- Inspection
- Jul 9 – Jul 13, 2018
- Investigator
- Tiki Dixon
- Observations
- 2
- Pages
- 4
- FEI number
- 1000305478
In short: On July 13, 2018, FDA issued a Form 483 with 2 observations to Bausch & Lomb, Incorporated in Lynchburg, Virginia (FEI 1000305478) after an inspection that ran Jul 9 – Jul 13, 2018. The investigator was Tiki Dixon. Most observations concern cAPA; the most-cited regulation is 21 CFR 820.90 (nonconforming product).
At a glance
2 of 2 observations on this 483 concern capa.
Most cited: 21 CFR 820.90(a) (1×) · 820.100(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Products that do not conform to specifications…
- 02
Procedures for corrective and preventive action have…
This inspection in context
Tiki Dixon
10 documents · 2016–2024
Cites 820.80(a) (receiving, in-process, and finished device acceptance) more than any other section. Most of their documents are for sites in Virginia.
The firmBausch & Lomb, Incorporated history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.90(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Bausch & Lomb, Incorporated?
FDA listed 2 observations on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 820.90 (nonconforming product). The opening words of each observation are shown on this page.
Who inspected Bausch & Lomb, Incorporated?
Tiki Dixon is named on this Form 483, for the inspection of Jul 9 – Jul 13, 2018. Each investigator has a profile showing what they cite most.
When was Bausch & Lomb, Incorporated inspected by FDA?
The inspection ran Jul 9 – Jul 13, 2018, and the Form 483 is dated July 13, 2018.
How do I get the full Form 483 for Bausch & Lomb, Incorporated?
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