Pfizer Pharmaceuticals LLC
Form 483 issued June 19, 2015 · Vega Baja, Puerto Rico
- Inspection
- Jun 8 – Jun 19, 2015
- Investigators
- Chelsea N. Sealey· Noreen Muniz
- Observations
- 5
- Pages
- 3
- FEI number
- 2623619
In short: On June 19, 2015, FDA issued a Form 483 with 5 observations to Pfizer Pharmaceuticals LLC in Vega Baja, Puerto Rico (FEI 2623619) after an inspection that ran Jun 8 – Jun 19, 2015. The investigators were Chelsea N. Sealey and Noreen Muniz. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and quality system account for 4 of 5 observations.
Most cited: 21 CFR 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory controls do not include a determination of conformance to appropriate…
- 02
Deviations from written test procedures and laboratory mechanisms are…
- 03
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 04
The responsibilities and procedures applicable to the quality control unit are not in…
This inspection in context
Chelsea N. Sealey
4 documents · 2015–2016
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in California.
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 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pfizer Pharmaceuticals LLC?
FDA listed 5 observations on this Form 483, mostly about laboratory controls, quality system and production. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Pfizer Pharmaceuticals LLC?
Chelsea N. Sealey and Noreen Muniz are named on this Form 483, for the inspection of Jun 8 – Jun 19, 2015. Each investigator has a profile showing what they cite most.
When was Pfizer Pharmaceuticals LLC inspected by FDA?
The inspection ran Jun 8 – Jun 19, 2015, and the Form 483 is dated June 19, 2015.
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.