Jamol Laboratories, Inc.
Form 483 issued December 12, 2024 · Emerson, New Jersey
- Inspection
- Dec 3 – Dec 12, 2024
- Investigators
- Emmanuel T. Donyina· Jessica S. Estriplet
- Observations
- 6
- Pages
- 6
- FEI number
- 2211383
In short: On December 12, 2024, FDA issued a Form 483 with 6 observations to Jamol Laboratories, Inc. in Emerson, New Jersey (FEI 2211383) after an inspection that ran Dec 3 – Dec 12, 2024. The investigators were Emmanuel T. Donyina and Jessica S. Estriplet. Most observations concern facilities & equipment and quality system.
At a glance
Facilities & equipment and quality system account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Your firm failed to establish written procedures for production and process controls designed to assure that…
- 02
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 03
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 04
Laboratory controls do not include the establishment of scientifically sormd and appropriate specifications, standards, sampling plans…
This inspection in context
Emmanuel T. Donyina
3 documents · 2024
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in New York.
The firmJamol Laboratories, Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Jamol Laboratories, Inc.?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment, quality system and production. The opening words of each observation are shown on this page.
Who inspected Jamol Laboratories, Inc.?
Emmanuel T. Donyina and Jessica S. Estriplet are named on this Form 483, for the inspection of Dec 3 – Dec 12, 2024. Each investigator has a profile showing what they cite most.
When was Jamol Laboratories, Inc. inspected by FDA?
The inspection ran Dec 3 – Dec 12, 2024, and the Form 483 is dated December 12, 2024.
How do I get the full Form 483 for Jamol 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.