Strides Pharma, Inc.
Form 483 issued June 5, 2019 · Chestnut Ridge, New York
- Inspection
- May 20 – Jun 5, 2019
- Investigator
- Sony Mathews
- Observations
- 2
- Pages
- 6
- FEI number
- 2434223
In short: On June 5, 2019, FDA issued a Form 483 with 2 observations to Strides Pharma, Inc. in Chestnut Ridge, New York (FEI 2434223) after an inspection that ran May 20 – Jun 5, 2019. The investigator was Sony Mathews. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.67 (1×) · 211.160 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
This inspection in context
Sony Mathews
22 documents · 2010–2022
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in New York.
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 211.67
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 facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Strides Pharma, Inc.?
Sony Mathews is named on this Form 483, for the inspection of May 20 – Jun 5, 2019. Each investigator has a profile showing what they cite most.
When was Strides Pharma, Inc. inspected by FDA?
The inspection ran May 20 – Jun 5, 2019, and the Form 483 is dated June 5, 2019.
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.