Pfizer Pharmaceuticals LLC
Form 483 issued January 26, 2018 · Vega Baja, Puerto Rico
- Inspection
- Jan 10, 2018
- Investigators
- Jose Velez· Marian E. Ramirez
- Observations
- 1
- Pages
- 2
In short: On January 26, 2018, FDA issued a Form 483 with 1 observation to Pfizer Pharmaceuticals LLC in Vega Baja, Puerto Rico after an inspection that ran Jan 10, 2018. The investigators were Jose Velez and Marian E. Ramirez. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has…
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 firmPfizer Pharmaceuticals LLC history
All 4 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 Pfizer Pharmaceuticals LLC?
FDA listed 1 observation on this Form 483, mostly about quality system. 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 Pfizer Pharmaceuticals LLC?
Jose Velez and Marian E. Ramirez are named on this Form 483, for the inspection of Jan 10, 2018. Each investigator has a profile showing what they cite most.
When was Pfizer Pharmaceuticals LLC inspected by FDA?
The inspection ran Jan 10, 2018, and the Form 483 is dated January 26, 2018.
How do I get the full Form 483 for Pfizer Pharmaceuticals 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.