Pharmalucence
Form 483 issued June 29, 2016 · Bedford, Massachusetts
- Inspection
- Jun 13 – Jun 29, 2016
- Investigators
- Erik W. Koester· Robert J. Martin
- Observations
- 4
- Pages
- 9
- FEI number
- 1219718
In short: On June 29, 2016, FDA issued a Form 483 with 4 observations to Pharmalucence in Bedford, Massachusetts (FEI 1219718) after an inspection that ran Jun 13 – Jun 29, 2016. The investigators were Erik W. Koester and Robert J. Martin. Most observations concern quality system.
At a glance
Observations span 1 system, 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
An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning…
- 03
The responsibilities and procedures applicable to the quality control unit…
- 04
/2016( Wed),6/23/2016(Thu),6/27/2016(Mon),6/28/2016(Tue),6/29/2016(…
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 history
The site's inspection history, in date order.
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?
FDA listed 4 observations on this Form 483, mostly about quality system. The opening words of each observation are shown on this page.
Who inspected Pharmalucence?
Erik W. Koester and Robert J. Martin are named on this Form 483, for the inspection of Jun 13 – Jun 29, 2016. Each investigator has a profile showing what they cite most.
When was Pharmalucence inspected by FDA?
The inspection ran Jun 13 – Jun 29, 2016, and the Form 483 is dated June 29, 2016.
How do I get the full Form 483 for Pharmalucence?
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.