PPL Pharma Solutions Riverview LLC
Form 483 issued November 18, 2004 · Riverview, Michigan
- Inspection
- Nov 4 – Nov 18, 2004
- Observations
- 6
- Pages
- 1
- FEI number
- 1824725
In short: On November 18, 2004, FDA issued a Form 483 with 6 observations to PPL Pharma Solutions Riverview LLC in Riverview, Michigan (FEI 1824725) after an inspection that ran Nov 4 – Nov 18, 2004. Most observations concern laboratory controls and materials; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Observations span 4 systems, led by laboratory controls.
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
Observation 1: scanned text, readable in the full document.
- 02
The identity of raw material, (b) (4), is not verified by conducting, at least, one specific…
- 03
Access to all of the (b) (4) HPLC systems in the laboratory is not controlled in…
- 04
There is no established written procedure which describes the use of formulas in conjunction…
This inspection in context
Questions about this 483
What did FDA find at PPL Pharma Solutions Riverview LLC?
FDA listed 6 observations on this Form 483, mostly about laboratory controls, materials 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.
When was PPL Pharma Solutions Riverview LLC inspected by FDA?
The inspection ran Nov 4 – Nov 18, 2004, and the Form 483 is dated November 18, 2004.
How do I get the full Form 483 for PPL Pharma Solutions Riverview 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.