Edlaw Pharmaceutical, Inc

FDA inspection history in Farmingdale, New York, 2019

1
Form 483

Every document, by year

  • Form 483

2019: one Form 483.

The story so far

Built from the dates and citations on the documents themselves.

  1. 2019One Form 483, at Farmingdale, New York.

Cited most

Across all Edlaw Pharmaceutical observations on file

  • 21 CFR 803.17
    What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?
    1
  • 21 CFR 820.22
    Quality audit
    1

The complete Edlaw Pharmaceutical file.

All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.

$99

The documents one by one, while the file is prepared

See the documents

Sites

Documents

1 on file, newest first
DateDocumentPrice
2019-11-27483 Form 483$99

Investigators on these documents

Kwong P. Lee (1)

FEI number 2431908 · most recent document Nov 27, 2019

About Edlaw Pharmaceutical, Inc

How many FDA Form 483s has Edlaw Pharmaceutical, Inc received?

FDA Intel has 1 Form 483 on file for Edlaw Pharmaceutical, Inc; the most recent is dated Nov 27, 2019.

When was Edlaw Pharmaceutical, Inc last inspected by FDA?

The most recent FDA inspection document on file for Edlaw Pharmaceutical, Inc is a Form 483 dated Nov 27, 2019, for the site in Farmingdale, New York.

What did FDA cite at Edlaw Pharmaceutical, Inc?

The regulations cited most in the observations on file for Edlaw Pharmaceutical, Inc are 21 CFR 803.17 (What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?), 1 time; 21 CFR 820.22 (Quality audit), 1 time.