PPL Pharma Solutions Riverview LLC
Form 483 issued December 22, 2010 · Riverview, Michigan
- Inspection
- Feb 21 – Dec 22, 2010
- Observations
- 2
- Pages
- 1
- FEI number
- 1824725
In short: On December 22, 2010, FDA issued a Form 483 with 2 observations to PPL Pharma Solutions Riverview LLC in Riverview, Michigan (FEI 1824725) after an inspection that ran Feb 21 – Dec 22, 2010. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.170 (reserve samples).
At a glance
Laboratory controls and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.170 (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
API product reserve sample are not stored in an immediate packaging system that is equivalent to…
- 02
Written procedures for equipment maintenance fail to include specific…
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 laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.170 (reserve samples). The opening words of each observation are shown on this page.
When was PPL Pharma Solutions Riverview LLC inspected by FDA?
The inspection ran Feb 21 – Dec 22, 2010, and the Form 483 is dated December 22, 2010.
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.