Strides Pharma, Inc.
Form 483 issued February 8, 2022 · Chestnut Ridge, New York
- Inspection
- Jan 27 – Feb 8, 2022
- Investigators
- Guerlain Ulysse· Janet A. Rajan
- Observations
- 2
- Pages
- 2
- FEI number
- 2434223
In short: On February 8, 2022, FDA issued a Form 483 with 2 observations to Strides Pharma, Inc. in Chestnut Ridge, New York (FEI 2434223) after an inspection that ran Jan 27 – Feb 8, 2022. The investigators were Guerlain Ulysse and Janet A. Rajan. Most observations concern laboratory controls and packaging & labeling.
At a glance
Laboratory controls and packaging & labeling 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
Established laboratory control mechanisms are not followed and documented at…
- 02
Inspection of the packaging and labeling facilities is [NEM to assure that materials not suitable for…
This inspection in context
Guerlain Ulysse
32 documents · 2016–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmStrides Pharma, 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 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Strides Pharma, Inc.?
FDA listed 2 observations on this Form 483, mostly about laboratory controls and packaging & labeling. The opening words of each observation are shown on this page.
Who inspected Strides Pharma, Inc.?
Guerlain Ulysse and Janet A. Rajan are named on this Form 483, for the inspection of Jan 27 – Feb 8, 2022. Each investigator has a profile showing what they cite most.
When was Strides Pharma, Inc. inspected by FDA?
The inspection ran Jan 27 – Feb 8, 2022, and the Form 483 is dated February 8, 2022.
How do I get the full Form 483 for Strides Pharma, 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.