Edlaw Pharmaceutical, Inc
Form 483 issued November 27, 2019 · Farmingdale, New York
- Inspection
- Nov 25 – Nov 27, 2019
- Investigator
- Kwong P. Lee
- Observations
- 2
- Pages
- 3
- FEI number
- 2431908
In short: On November 27, 2019, FDA issued a Form 483 with 2 observations to Edlaw Pharmaceutical, Inc in Farmingdale, New York (FEI 2431908) after an inspection that ran Nov 25 – Nov 27, 2019. The investigator was Kwong P. Lee. Most observations concern cAPA and management controls; the most-cited regulation is 21 CFR 803.17 (what are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?).
At a glance
CAPA and management controls account for 2 of 2 observations.
Most cited: 21 CFR 803.17 (1×) · 820.22 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Written MDR procedures have…
- 02
Quality audits were not performed at defined intervals to determine whether the quality system activities and…
This inspection in context
Kwong P. Lee
12 documents · 2015–2026
Cites 820.30(c) (design controls) more than any other section. Most of their documents are for sites in New York.
The firmEdlaw Pharmaceutical, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 803.17
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Edlaw Pharmaceutical, Inc?
FDA listed 2 observations on this Form 483, mostly about cAPA and management controls. The most-cited regulation is 21 CFR 803.17 (what are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?). The opening words of each observation are shown on this page.
Who inspected Edlaw Pharmaceutical, Inc?
Kwong P. Lee is named on this Form 483, for the inspection of Nov 25 – Nov 27, 2019. Each investigator has a profile showing what they cite most.
When was Edlaw Pharmaceutical, Inc inspected by FDA?
The inspection ran Nov 25 – Nov 27, 2019, and the Form 483 is dated November 27, 2019.
How do I get the full Form 483 for Edlaw Pharmaceutical, Inc?
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