PF Consumer Healthcare B.V. (Puerto Rico Operations) LLC
Form 483 issued August 17, 2018 · Guayama, Puerto Rico
- Inspection
- Aug 9 – Aug 17, 2018
- Investigator
- Jose Velez
- Observations
- 2
- Pages
- 4
- FEI number
- 3007343300
In short: On August 17, 2018, FDA issued a Form 483 with 2 observations to PF Consumer Healthcare B.V. (Puerto Rico Operations) LLC in Guayama, Puerto Rico (FEI 3007343300) after an inspection that ran Aug 9 – Aug 17, 2018. The investigator was Jose Velez. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.160(b)(3) (1×) · 211.67(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Laboratory controls do not include a determination of conformance to appropriate…
- 02
Observation 2: scanned text, readable in the full document.
This inspection in context
Jose Velez
24 documents · 2014–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Puerto Rico.
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 211.160(b)(3)
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 2 observations on this Form 483, mostly about laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected PF Consumer Healthcare B.V. (Puerto Rico Operations) LLC?
Jose Velez is named on this Form 483, for the inspection of Aug 9 – Aug 17, 2018. 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 Aug 9 – Aug 17, 2018, and the Form 483 is dated August 17, 2018.
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.