EyePoint Pharmaceuticals US, Inc.
Form 483 issued February 15, 2024 · Watertown, Massachusetts
- Inspection
- Feb 6 – Feb 15, 2024
- Investigator
- Daniel L. Zheng
- Observations
- 7
- Pages
- 13
- FEI number
- 3005508657
In short: On February 15, 2024, FDA issued a Form 483 with 7 observations to EyePoint Pharmaceuticals US, Inc. in Watertown, Massachusetts (FEI 3005508657) after an inspection that ran Feb 6 – Feb 15, 2024. The investigator was Daniel L. Zheng. Most observations concern production and quality system.
At a glance
Production and quality system account for 5 of 7 observations.
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 whether or not the batch…
- 02
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 03
Deviations from written production and process control…
- 04
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would…
This inspection in context
Daniel L. Zheng
24 documents · 2020–2026
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 7 observations on this Form 483, mostly about production, quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected EyePoint Pharmaceuticals US, Inc.?
Daniel L. Zheng is named on this Form 483, for the inspection of Feb 6 – Feb 15, 2024. Each investigator has a profile showing what they cite most.
When was EyePoint Pharmaceuticals US, Inc. inspected by FDA?
The inspection ran Feb 6 – Feb 15, 2024, and the Form 483 is dated February 15, 2024.
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.