PPL Pharma Solutions Riverview LLC
Form 483 issued December 21, 2000 · Riverview, Michigan
- Inspection
- Oct 30 – Dec 21, 2000
- Investigators
- Cheryl M. Monroe· Jeffrey C. Pruim
- Observations
- 19
- Pages
- 5
- FEI number
- 1824725
In short: On December 21, 2000, FDA issued a Form 483 with 19 observations to PPL Pharma Solutions Riverview LLC in Riverview, Michigan (FEI 1824725) after an inspection that ran Oct 30 – Dec 21, 2000. The investigators were Cheryl M. Monroe and Jeffrey C. Pruim. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and facilities & equipment account for 15 of 19 observations.
Most cited: 21 CFR 211.192 (6×) · 211.67 (5×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Brimonidine Tartrate and its various intermediates are produced using(b) (4) (b) (4). Cleaning Validation for Brimonidine…
- 02
The following are instances where equipment required (b) (4) cleaning and the cleaning batch records did…
- 03
There is no documentated cleaning validation or…
- 04
Your Quality Control Unit has no system in place to assure employees have the training necessary…
This inspection in context
Cheryl M. Monroe
1 document · 2000
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Michigan.
The firmPPL Pharma Solutions Riverview 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 PPL Pharma Solutions Riverview LLC?
FDA listed 19 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. 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 PPL Pharma Solutions Riverview LLC?
Cheryl M. Monroe and Jeffrey C. Pruim are named on this Form 483, for the inspection of Oct 30 – Dec 21, 2000. Each investigator has a profile showing what they cite most.
When was PPL Pharma Solutions Riverview LLC inspected by FDA?
The inspection ran Oct 30 – Dec 21, 2000, and the Form 483 is dated December 21, 2000.
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.