Bausch & Lomb, Inc.
Form 483 issued August 10, 2018 · Tampa, Florida
- Inspection
- Jul 30 – Aug 10, 2018
- Investigators
- Ileana Barreto-Pettit· Latorie S. Jones
- Observations
- 1
- Pages
- 10
- FEI number
- 1000113778
In short: On August 10, 2018, FDA issued a Form 483 with 1 observation to Bausch & Lomb, Inc. in Tampa, Florida (FEI 1000113778) after an inspection that ran Jul 30 – Aug 10, 2018. The investigators were Ileana Barreto-Pettit and Latorie S. Jones. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22(d) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
This inspection in context
Ileana Barreto-Pettit
25 documents · 2001–2022
Cites 211.42 (design and construction features) 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 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Bausch & Lomb, Inc.?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Bausch & Lomb, Inc.?
Ileana Barreto-Pettit and Latorie S. Jones are named on this Form 483, for the inspection of Jul 30 – Aug 10, 2018. Each investigator has a profile showing what they cite most.
When was Bausch & Lomb, Inc. inspected by FDA?
The inspection ran Jul 30 – Aug 10, 2018, and the Form 483 is dated August 10, 2018.
How do I get the full Form 483 for Bausch & Lomb, Inc.?
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