Bausch & Lomb, Inc.
Form 483 issued May 26, 2017 · Tampa, Florida
- Inspection
- May 15 – May 26, 2017
- Investigators
- Ileana Barreto-Pettit· Jennifer L. Huntington· Ruo H. Xu
- Observations
- 11
- Pages
- 12
- FEI number
- 1000113778
In short: On May 26, 2017, FDA issued a Form 483 with 11 observations to Bausch & Lomb, Inc. in Tampa, Florida (FEI 1000113778) after an inspection that ran May 15 – May 26, 2017. The investigators were Ileana Barreto-Pettit, Jennifer L. Huntington, Ruo H. Xu and Wendy G. Tan. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Observations span 4 systems, led by production.
Most cited: 21 CFR 211.192 (3×) · 211.42 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent objectionable microorganisms in drug products not required to be…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Actual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate…
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Bausch & Lomb, Inc.?
FDA listed 11 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Bausch & Lomb, Inc.?
Ileana Barreto-Pettit, Jennifer L. Huntington, Ruo H. Xu and Wendy G. Tan are named on this Form 483, for the inspection of May 15 – May 26, 2017. Each investigator has a profile showing what they cite most.
When was Bausch & Lomb, Inc. inspected by FDA?
The inspection ran May 15 – May 26, 2017, and the Form 483 is dated May 26, 2017.
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.