PPL Pharma Solutions Riverview LLC
Form 483 issued July 16, 2009 · Riverview, Michigan
- Observations
- 2
- Pages
- 1
- FEI number
- 1824725
In short: On July 16, 2009, FDA issued a Form 483 with 2 observations to PPL Pharma Solutions Riverview LLC in Riverview, Michigan (FEI 1824725). Most observations concern materials and facilities & equipment; the most-cited regulation is 21 CFR 211.80 (general requirements).
At a glance
Materials and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.80 (1×) · 211.67 (1×)
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
Written procedures are not followed for the Preventative Maintenance of production equipment used in the manufacture…
This inspection in context
Questions about this 483
What did FDA find at PPL Pharma Solutions Riverview LLC?
FDA listed 2 observations on this Form 483, mostly about materials and facilities & equipment. The most-cited regulation is 21 CFR 211.80 (general requirements). The opening words of each observation are shown on this page.
When was PPL Pharma Solutions Riverview LLC inspected by FDA?
This Form 483 is dated July 16, 2009.
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.