Form 483
Form 483 issued December 21, 2016 · Tuckahoe, New York
- Inspection
- Dec 1 – Dec 21, 2016
- Investigator
- Helen B. Ricalde
- Observations
- 13
- Pages
- 6
- FEI number
- 3008189622
In short: On December 21, 2016, FDA issued a Form 483 with 13 observations to an FDA-inspected site in Tuckahoe, New York (FEI 3008189622) after an inspection that ran Dec 1 – Dec 21, 2016. The investigator was Helen B. Ricalde. Most observations concern quality system and production.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observation- 01
There is no quality…
- 02
There are no written procedures for production and process controls designed to assure that the drug…
- 03
Employees are not given training in…
- 04
Procedures describing the handling of written and oral complaints related to drug products are…
This inspection in context
Helen B. Ricalde
9 documents · 2003–2023
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New York.
The firmSite history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 13 observations on this Form 483, mostly about quality system, production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Helen B. Ricalde is named on this Form 483, for the inspection of Dec 1 – Dec 21, 2016. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Dec 1 – Dec 21, 2016, and the Form 483 is dated December 21, 2016.
How do I get the full Form 483 for an FDA-inspected site?
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.