PF Consumer Healthcare B.V. (Puerto Rico Operations) LLC
Form 483 issued November 17, 2014 · Guayama, Puerto Rico
- Inspection
- Oct 14 – Nov 17, 2014
- Investigator
- Jose R. Lopez
- Observations
- 4
- Pages
- 6
- FEI number
- 3007343300
In short: On November 17, 2014, FDA issued a Form 483 with 4 observations to PF Consumer Healthcare B.V. (Puerto Rico Operations) LLC in Guayama, Puerto Rico (FEI 3007343300) after an inspection that ran Oct 14 – Nov 17, 2014. The investigator was Jose R. Lopez. Most observations concern quality system and materials; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and materials 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
Observation 2: scanned text, readable in the full document.
- 03
Observation 3: scanned text, readable in the full document.
- 04
Products impacted by “non-approved” change controls were inadvertently…
This inspection in context
Jose R. Lopez
7 documents · 2010–2026
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Florida.
The firmPF Consumer Healthcare B.V. (Puerto Rico Operations) LLC history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at PF Consumer Healthcare B.V. (Puerto Rico Operations) LLC?
FDA listed 4 observations on this Form 483, mostly about quality system, materials and production. 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 PF Consumer Healthcare B.V. (Puerto Rico Operations) LLC?
Jose R. Lopez is named on this Form 483, for the inspection of Oct 14 – Nov 17, 2014. Each investigator has a profile showing what they cite most.
When was PF Consumer Healthcare B.V. (Puerto Rico Operations) LLC inspected by FDA?
The inspection ran Oct 14 – Nov 17, 2014, and the Form 483 is dated November 17, 2014.
How do I get the full Form 483 for PF Consumer Healthcare B.V. (Puerto Rico Operations) LLC?
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.