Strides Pharma, Inc.
Form 483 issued June 4, 2015 · Chestnut Ridge, New York
- Inspection
- May 11 – Jun 4, 2015
- Investigators
- Mindy M. Chou· Sony Mathews
- Observations
- 7
- Pages
- 4
- FEI number
- 2434223
In short: On June 4, 2015, FDA issued a Form 483 with 7 observations to Strides Pharma, Inc. in Chestnut Ridge, New York (FEI 2434223) after an inspection that ran May 11 – Jun 4, 2015. The investigators were Mindy M. Chou and Sony Mathews. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Laboratory controls and quality system account for 7 of 7 observations.
Most cited: 21 CFR 211.192 (3×) · 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The quality control unit lacks authority to fully investigate…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
The Observations are related…
- 04
There are no written procedures for production and process controls designed to assure that the drug…
This inspection in context
Mindy M. Chou
37 documents · 2015–2026
Cites 211.113 (control of microbiological contamination) 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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Strides Pharma, Inc.?
FDA listed 7 observations on this Form 483, mostly about laboratory controls and quality system. 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 Strides Pharma, Inc.?
Mindy M. Chou and Sony Mathews are named on this Form 483, for the inspection of May 11 – Jun 4, 2015. Each investigator has a profile showing what they cite most.
When was Strides Pharma, Inc. inspected by FDA?
The inspection ran May 11 – Jun 4, 2015, and the Form 483 is dated June 4, 2015.
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.