Pharmalucence, Inc
Form 483 issued November 13, 2017 · Billerica, Massachusetts
- Inspection
- Oct 25 – Nov 13, 2017
- Investigators
- Erik W. Koester· Robert J. Martin
- Observations
- 3
- Pages
- 4
- FEI number
- 3009395771
In short: On November 13, 2017, FDA issued a Form 483 with 3 observations to Pharmalucence, Inc in Billerica, Massachusetts (FEI 3009395771) after an inspection that ran Oct 25 – Nov 13, 2017. The investigators were Erik W. Koester and Robert J. Martin. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Routine calibration of electronic equipment is not performed according to a written program designed…
- 03
The written stability testing…
This inspection in context
Erik W. Koester
40 documents · 2006–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Massachusetts.
The firmPharmalucence, Inc history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pharmalucence, Inc?
FDA listed 3 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Pharmalucence, Inc?
Erik W. Koester and Robert J. Martin are named on this Form 483, for the inspection of Oct 25 – Nov 13, 2017. Each investigator has a profile showing what they cite most.
When was Pharmalucence, Inc inspected by FDA?
The inspection ran Oct 25 – Nov 13, 2017, and the Form 483 is dated November 13, 2017.
How do I get the full Form 483 for Pharmalucence, Inc?
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.