Ocular Therapculix, Inc.
Form 483 issued February 5, 2016 · Bedford, Massachusetts
- Inspection
- Feb 1 – Feb 5, 2016
- Investigators
- Edmund F. Mrak Jr· Jonathan G. Matrisciano
- Observations
- 10
- Pages
- 9
- FEI number
- 3008477155
In short: On February 5, 2016, FDA issued a Form 483 with 10 observations to Ocular Therapculix, Inc. in Bedford, Massachusetts (FEI 3008477155) after an inspection that ran Feb 1 – Feb 5, 2016. The investigators were Edmund F. Mrak Jr and Jonathan G. Matrisciano. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Production and laboratory controls account for 7 of 10 observations.
Most cited: 21 CFR 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory records do not include a complete record ofall data secured in the course ofeach test…
- 02
Samples taken of drug products for determination of conformance to written…
- 03
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
- 04
Actual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate…
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 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 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Ocular Therapculix, Inc.?
FDA listed 10 observations on this Form 483, mostly about production, laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Ocular Therapculix, Inc.?
Edmund F. Mrak Jr and Jonathan G. Matrisciano are named on this Form 483, for the inspection of Feb 1 – Feb 5, 2016. Each investigator has a profile showing what they cite most.
When was Ocular Therapculix, Inc. inspected by FDA?
The inspection ran Feb 1 – Feb 5, 2016, and the Form 483 is dated February 5, 2016.
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.