Exemplar Pharmaceuticals LLC
Form 483 issued March 21, 2012 · Fall River, Massachusetts
- Inspection
- Mar 21, 2012
- Investigators
- Edmund F. Mrak Jr· Maya M. Davis
- Observations
- 2
- Pages
- 2
- FEI number
- 3006571100
In short: On March 21, 2012, FDA issued a Form 483 with 2 observations to Exemplar Pharmaceuticals LLC in Fall River, Massachusetts (FEI 3006571100) after an inspection that ran Mar 21, 2012. The investigators were Edmund F. Mrak Jr and Maya M. Davis. Most observations concern production; the most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products).
At a glance
2 of 2 observations on this 483 concern production.
Most cited: 21 CFR 211.110 (1×) · 211.100 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The in process control procedures were deficient in that they did not include an examination ofthe…
- 02
There are no written procedures for production and process controls designed to assure that the drug…
This inspection in context
Edmund F. Mrak Jr
7 documents · 2012–2022
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Massachusetts.
The firmExemplar Pharmaceuticals LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.110
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Exemplar Pharmaceuticals LLC?
FDA listed 2 observations on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products). The opening words of each observation are shown on this page.
Who inspected Exemplar Pharmaceuticals LLC?
Edmund F. Mrak Jr and Maya M. Davis are named on this Form 483, for the inspection of Mar 21, 2012. Each investigator has a profile showing what they cite most.
When was Exemplar Pharmaceuticals LLC inspected by FDA?
The inspection ran Mar 21, 2012, and the Form 483 is dated March 21, 2012.
How do I get the full Form 483 for Exemplar 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.