FDA Inspection
Gram Laboratories IncGram Laboratories Inc – FDA Inspection, Apr 8, 2025
Record Details
This FDA Inspection record concerns Gram Laboratories Inc, with an inspection on April 8, 2025, issued by the Los Angeles District Office, covering human drugs.
- Person
View Company Profile
ID · 9570c141-14be-4268-a593-3353ab54531c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1269575
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.192Written record of investigation incomplete
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Gram Laboratories Inc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| September 19, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 4, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 30, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 13, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 16, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Gram Laboratories Inc
- FDA Inspection 1068237 - 2018-09-19
- FDA Inspection 941212 - 2015-09-04
- FDA Inspection 805255 - 2012-10-30
- FDA Inspection 733887 - 2011-07-13
- FDA Inspection 645522 - 2010-02-16
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.