FDA Intel

Syntec Pharma Corp

FDA inspection history in Farmingdale, New York, 2020 to 2021

1
Warning letter
1
Form 483

Every document, by year

  • Warning letter
  • Form 483

2020: one Form 483; 2021: one warning letter.

The story so far

Built from the dates and citations on the documents themselves.

  1. 2020–21One Form 483 and one warning letter, at Farmingdale, New York.

Cited most

Across all Syntec Pharma observations on file

The complete Syntec Pharma file.

All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.

$198

The price of the documents, added to your cart together

Sites

Documents

2 on file, newest first
DateDocumentPrice
2021-07-06Warning letter Warning letter$99
2020-10-28483 Form 483$99

Investigators on these documents

Jay T. Wong (1)Vivin George (1)

FEI number 3010057717 · most recent document Jul 6, 2021

About Syntec Pharma Corp

How many FDA Form 483s has Syntec Pharma Corp received?

FDA Intel has 1 Form 483 on file for Syntec Pharma Corp; the most recent is dated Oct 28, 2020.

When was Syntec Pharma Corp last inspected by FDA?

The most recent FDA inspection document on file for Syntec Pharma Corp is a Form 483 dated Oct 28, 2020, for the site in Farmingdale, New York.

What did FDA cite at Syntec Pharma Corp?

The regulations cited most in the observations on file for Syntec Pharma Corp are 21 CFR 211.42 (Design and construction features), 2 times; 21 CFR 211.100 (Written procedures; deviations), 1 time; 21 CFR 211.150 (Distribution procedures), 1 time.

Has Syntec Pharma Corp received an FDA warning letter?

Yes. FDA Intel has 1 FDA warning letter on file for Syntec Pharma Corp; the most recent is dated Jul 6, 2021.

Syntec Pharma Corp FDA Inspection History & 483s · FDA Intel