Ocular Therapculix, Inc.
Form 483 issued May 4, 2017 · Bedford, Massachusetts
- Inspection
- Apr 24 – May 4, 2017
- Investigator
- Nealie C. Newberger
- Observations
- 6
- Pages
- 7
- FEI number
- 3008477155
In short: On May 4, 2017, FDA issued a Form 483 with 6 observations to Ocular Therapculix, Inc. in Bedford, Massachusetts (FEI 3008477155) after an inspection that ran Apr 24 – May 4, 2017. The investigator was Nealie C. Newberger. Most observations concern quality system and production.
At a glance
Quality system and production account for 5 of 6 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written records are not always made of…
- 02
Written production and process control procedures are not followed in the execution of production and process…
- 03
There are no written procedures for production and process controls designed to assure that the drug…
- 04
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Nealie C. Newberger
9 documents · 2016–2017
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Connecticut.
The firmOcular Therapculix, 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 Ocular Therapculix, Inc.?
FDA listed 6 observations on this Form 483, mostly about quality system, production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Ocular Therapculix, Inc.?
Nealie C. Newberger is named on this Form 483, for the inspection of Apr 24 – May 4, 2017. Each investigator has a profile showing what they cite most.
When was Ocular Therapculix, Inc. inspected by FDA?
The inspection ran Apr 24 – May 4, 2017, and the Form 483 is dated May 4, 2017.
How do I get the full Form 483 for Ocular Therapculix, 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.