Jamol Laboratories, Inc.
Form 483 issued January 12, 2023 · Emerson, New Jersey
- Inspection
- Dec 5, 2022 – Jan 12, 2023
- Investigator
- Jessica S. Estriplet
- Observations
- 4
- Pages
- 5
- FEI number
- 2211383
In short: On January 12, 2023, FDA issued a Form 483 with 4 observations to Jamol Laboratories, Inc. in Emerson, New Jersey (FEI 2211383) after an inspection that ran Dec 5, 2022 – Jan 12, 2023. The investigator was Jessica S. Estriplet. Most observations concern production and facilities & equipment.
At a glance
Production and facilities & equipment account for 3 of 4 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
Buildings used in the manufacture, processing, packing, or holding of a drug product do not have…
- 03
Written records are not always made of…
- 04
Batch production and control records do not include complete information relating to the production and…
This inspection in context
Jessica S. Estriplet
18 documents · 2021–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in New Jersey.
The 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 4 observations on this Form 483, mostly about production, facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected Jamol Laboratories, Inc.?
Jessica S. Estriplet is named on this Form 483, for the inspection of Dec 5, 2022 – Jan 12, 2023. Each investigator has a profile showing what they cite most.
When was Jamol Laboratories, Inc. inspected by FDA?
The inspection ran Dec 5, 2022 – Jan 12, 2023, and the Form 483 is dated January 12, 2023.
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.