Parker Laboratories, Inc
Form 483 issued June 14, 2023 · Fairfield, New Jersey
- Inspection
- May 24 – Jun 14, 2023
- Investigator
- Helen Verdel
- Observations
- 5
- Pages
- 3
- FEI number
- 2212018
In short: On June 14, 2023, FDA issued a Form 483 with 5 observations to Parker Laboratories, Inc in Fairfield, New Jersey (FEI 2212018) after an inspection that ran May 24 – Jun 14, 2023. The investigator was Helen Verdel. Most observations concern production and laboratory controls.
At a glance
Production and laboratory controls account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is no written testing program designed to assess the stability…
- 02
The batch production and control records do not include a statement of the actual yield and…
- 03
Yom* firm failed to establish written procedures for production and process controls designed to assure that…
- 04
Written procedures are not followed for evaluations done at least annually and including provisions for a…
This inspection in context
Helen Verdel
13 documents · 2015–2023
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in New Jersey.
The firmParker Laboratories, Inc history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.166(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Parker Laboratories, Inc?
FDA listed 5 observations on this Form 483, mostly about production, laboratory controls and quality system. The opening words of each observation are shown on this page.
Who inspected Parker Laboratories, Inc?
Helen Verdel is named on this Form 483, for the inspection of May 24 – Jun 14, 2023. Each investigator has a profile showing what they cite most.
When was Parker Laboratories, Inc inspected by FDA?
The inspection ran May 24 – Jun 14, 2023, and the Form 483 is dated June 14, 2023.
How do I get the full Form 483 for Parker 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.