Pharmalucence, Inc
Form 483 issued December 23, 2019 · Billerica, Massachusetts
- Inspection
- Dec 5 – Dec 23, 2019
- Investigators
- Erik W. Koester· Robert J. Martin
- Observations
- 4
- Pages
- 6
- FEI number
- 3009395771
In short: On December 23, 2019, FDA issued a Form 483 with 4 observations to Pharmalucence, Inc in Billerica, Massachusetts (FEI 3009395771) after an inspection that ran Dec 5 – Dec 23, 2019. The investigators were Erik W. Koester and Robert J. Martin. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Routine calibration, inspection and checking of automatic, mechanical and electronic equipment is not performed according to…
- 03
Specific identification tests are not conducted on components that have been accepted based on the…
- 04
Reserve drug product samples are not retained and stored under conditions…
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pharmalucence, Inc?
FDA listed 4 observations on this Form 483, mostly about quality system, facilities & equipment and materials. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). 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 Dec 5 – Dec 23, 2019. Each investigator has a profile showing what they cite most.
When was Pharmalucence, Inc inspected by FDA?
The inspection ran Dec 5 – Dec 23, 2019, and the Form 483 is dated December 23, 2019.
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.