EyePoint Pharmaceuticals US, Inc.
Form 483 issued August 28, 2019 · Watertown, Massachusetts
- Inspection
- Jul 29 – Aug 28, 2019
- Investigators
- Chhaya S. Shetty· Erik W. Koester
- Observations
- 9
- Pages
- 13
- FEI number
- 3005508657
In short: On August 28, 2019, FDA issued a Form 483 with 9 observations to EyePoint Pharmaceuticals US, Inc. in Watertown, Massachusetts (FEI 3005508657) after an inspection that ran Jul 29 – Aug 28, 2019. The investigators were Chhaya S. Shetty and Erik W. Koester. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Facilities & equipment and quality system account for 7 of 9 observations.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observation- 01
Written records are not made of investigations into the failure of a batch or any of…
- 02
Examination and testing of samples is not done to assure that in-process…
- 03
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 04
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
This inspection in context
Chhaya S. Shetty
1 document · 2019
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Massachusetts.
The firmEyePoint Pharmaceuticals US, 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 EyePoint Pharmaceuticals US, Inc.?
FDA listed 9 observations on this Form 483, mostly about facilities & equipment, quality system and production. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected EyePoint Pharmaceuticals US, Inc.?
Chhaya S. Shetty and Erik W. Koester are named on this Form 483, for the inspection of Jul 29 – Aug 28, 2019. Each investigator has a profile showing what they cite most.
When was EyePoint Pharmaceuticals US, Inc. inspected by FDA?
The inspection ran Jul 29 – Aug 28, 2019, and the Form 483 is dated August 28, 2019.
How do I get the full Form 483 for EyePoint Pharmaceuticals US, 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.