Protein Sciences Corporation
Form 483 issued May 2, 2024 · Pearl River, New York
- Inspection
- Apr 23 – May 2, 2024
- Investigator
- Thai D. Truong
- Observations
- 7
- Pages
- 7
- FEI number
- 3011286996
In short: On May 2, 2024, FDA issued a Form 483 with 7 observations to Protein Sciences Corporation in Pearl River, New York (FEI 3011286996) after an inspection that ran Apr 23 – May 2, 2024. The investigator was Thai D. Truong. 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 5 of 7 observations.
Most cited: 21 CFR 211.192 (3×) · 211.42 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 02
Discrepancy and failure investigations related to manufacturing and testing were not expanded…
- 03
Your firm lacks assurance that all manufacturing deviations are documented, reviewed for product impact, or if…
- 04
Manufacturer No inventory system has been implemented for the tracking and…
This inspection in context
Thai D. Truong
12 documents · 2022–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Massachusetts.
The firmProtein Sciences Corporation history
All 2 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 Protein Sciences Corporation?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, quality system and laboratory controls. 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 Protein Sciences Corporation?
Thai D. Truong is named on this Form 483, for the inspection of Apr 23 – May 2, 2024. Each investigator has a profile showing what they cite most.
When was Protein Sciences Corporation inspected by FDA?
The inspection ran Apr 23 – May 2, 2024, and the Form 483 is dated May 2, 2024.
How do I get the full Form 483 for Protein Sciences Corporation?
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.