Forest/Inwood Laboratories, Inc.
Form 483 issued October 23, 1998 · Farmingdale, New York
- Inspection
- Oct 5 – Oct 23, 1998
- Investigators
- Gary Lehr· Lawrence Farina
- Observations
- 22
- Pages
- 6
In short: On October 23, 1998, FDA issued a Form 483 with 22 observations to Forest/Inwood Laboratories, Inc. in Farmingdale, New York after an inspection that ran Oct 5 – Oct 23, 1998. The investigators were Gary Lehr and Lawrence Farina. Most observations concern gLP; the most-cited regulation is 21 CFR 58.81 (standard operating procedures).
At a glance
18 of 22 observations on this 483 concern glp.
Most cited: 21 CFR 58.81 (12×) · 58.63 (5×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The SOP #F-001 entitied "Analytical Run Acceptance Criteria”…
- 02
SOP #F-001 permits calculation of accuracy of QCs using…
- 03
The reported assay precision in the analytical runs was not accurate because the precision analysis did…
- 04
There was no established…
This inspection in context
Gary Lehr
1 document · 1998
Cites 58.81 (standard operating procedures) more than any other section. Most of their documents are for sites in New York.
The firmForest/Inwood Laboratories, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 58.81
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Forest/Inwood Laboratories, Inc.?
FDA listed 22 observations on this Form 483, mostly about gLP. The most-cited regulation is 21 CFR 58.81 (standard operating procedures). The opening words of each observation are shown on this page.
Who inspected Forest/Inwood Laboratories, Inc.?
Gary Lehr and Lawrence Farina are named on this Form 483, for the inspection of Oct 5 – Oct 23, 1998. Each investigator has a profile showing what they cite most.
When was Forest/Inwood Laboratories, Inc. inspected by FDA?
The inspection ran Oct 5 – Oct 23, 1998, and the Form 483 is dated October 23, 1998.
How do I get the full Form 483 for Forest/Inwood Laboratories, 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.