GMP Laboratories of America, Inc.
Form 483 issued December 16, 2024 · Anaheim, California
- Inspection
- Dec 11 – Dec 16, 2024
- Investigators
- Gunneet Kaur· Tiara M. Brown
- Observations
- 4
- Pages
- 5
- FEI number
- 3002710875
In short: On December 16, 2024, FDA issued a Form 483 with 4 observations to GMP Laboratories of America, Inc. in Anaheim, California (FEI 3002710875) after an inspection that ran Dec 11 – Dec 16, 2024. The investigators were Gunneet Kaur and Tiara M. Brown. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Production and laboratory controls account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…
- 02
Your firm failed to establish written procedures for production and process controls designed to assure that…
- 03
Written production and process control procedures are not documented at…
- 04
Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods…
This inspection in context
Gunneet Kaur
9 documents · 2021–2024
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in California.
The firmGMP Laboratories of America, 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 211.194(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at GMP Laboratories of America, Inc.?
FDA listed 4 observations on this Form 483, mostly about production, laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected GMP Laboratories of America, Inc.?
Gunneet Kaur and Tiara M. Brown are named on this Form 483, for the inspection of Dec 11 – Dec 16, 2024. Each investigator has a profile showing what they cite most.
When was GMP Laboratories of America, Inc. inspected by FDA?
The inspection ran Dec 11 – Dec 16, 2024, and the Form 483 is dated December 16, 2024.
How do I get the full Form 483 for GMP Laboratories of America, 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.