Protein Sciences Corporation
Form 483 issued May 31, 2019 · Pearl River, New York
- Investigator
- Jacqueline Diaz-Albertini
- Observations
- 2
- Pages
- 4
- FEI number
- 3011286996
In short: On May 31, 2019, FDA issued a Form 483 with 2 observations to Protein Sciences Corporation in Pearl River, New York (FEI 3011286996). The investigator was Jacqueline Diaz-Albertini. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Quality system and laboratory controls account for 2 of 2 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Complaint investigations are incomplete, not closed out in a timely manner and standard operating procedures for…
- 02
Observation 2: scanned text, readable in the full document.
This inspection in context
Jacqueline Diaz-Albertini
7 documents · 1996–2021
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in New York.
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 211.198
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Protein Sciences Corporation?
FDA listed 2 observations on this Form 483, mostly about quality system and laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Protein Sciences Corporation?
Jacqueline Diaz-Albertini is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Protein Sciences Corporation inspected by FDA?
This Form 483 is dated May 31, 2019.
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.