FDA Inspection
Jamol Laboratories, Inc.Jamol Laboratories, Inc. – FDA Inspection, Dec 12, 2024
Record Details
This FDA Inspection record concerns Jamol Laboratories, Inc., with an inspection on December 12, 2024, issued by the New Jersey District Office, covering human drugs.
View Company Profile
ID · dffde0d3-8c83-454b-933e-a813de9e074f
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1256416
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.100(a)Absence of Written Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Jamol Laboratories, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| January 12, 2023 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 3, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 24, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 28, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Jamol Laboratories, Inc.
- FDA Inspection 1195290 - 2023-01-12
- FDA Inspection 980976 - 2016-08-03
- FDA Inspection 828881 - 2013-04-24
- FDA Inspection 715900 - 2011-03-28
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.