Reed-Lane, Inc.
Amended 483 issued March 3, 2023 · Wayne, New Jersey
- Inspection
- Feb 23 – Mar 3, 2023
- Investigator
- Anthony Donato
- Observations
- 1
- Pages
- 4
- FEI number
- 3002772224
In short: On March 3, 2023, FDA issued a Amended 483 with 1 observation to Reed-Lane, Inc. in Wayne, New Jersey (FEI 3002772224) after an inspection that ran Feb 23 – Mar 3, 2023. The investigator was Anthony Donato. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
1 of 1 observations on this amended 483 concern quality system.
Most cited: 21 CFR 211.22(d) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
The full amended 483
Plus the full detail behind each one, exactly as FDA wrote it.
Get the full amended 483This inspection in context
Anthony Donato
6 documents · 2020–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in New Jersey.
The firmReed-Lane, Inc. history
The site's inspection history, in date order.
Similar documentsOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this amended 483
What did FDA find at Reed-Lane, Inc.?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Reed-Lane, Inc.?
Anthony Donato is named on this Amended 483, for the inspection of Feb 23 – Mar 3, 2023. Each investigator has a profile showing what they cite most.
When was Reed-Lane, Inc. inspected by FDA?
The inspection ran Feb 23 – Mar 3, 2023, and the Amended 483 is dated March 3, 2023.
How do I get the full Amended 483 for Reed-Lane, 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.