GMP Laboratories of America, Inc.
Form 483 issued January 14, 2020 · Anaheim, California
- Inspection
- Jan 8 – Jan 14, 2020
- Investigator
- Taichun Qin
- Observations
- 5
- Pages
- 4
- FEI number
- 3002710875
In short: On January 14, 2020, FDA issued a Form 483 with 5 observations to GMP Laboratories of America, Inc. in Anaheim, California (FEI 3002710875) after an inspection that ran Jan 8 – Jan 14, 2020. The investigator was Taichun Qin. Most observations concern facilities & equipment and quality system.
At a glance
Facilities & equipment and quality system account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
There are no written procedures for production and process controls designed to assure that the drug…
- 03
Verification of the suitability of the testing methods is deficient in that they are not performed…
- 04
Equipment surfaces that contact drug products are reactive, additive or absorptive so as to alter the…
This inspection in context
Taichun Qin
35 documents · 2017–2025
Cites 211.113 (control of microbiological contamination) 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 211.22(d)
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 5 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 GMP Laboratories of America, Inc.?
Taichun Qin is named on this Form 483, for the inspection of Jan 8 – Jan 14, 2020. Each investigator has a profile showing what they cite most.
When was GMP Laboratories of America, Inc. inspected by FDA?
The inspection ran Jan 8 – Jan 14, 2020, and the Form 483 is dated January 14, 2020.
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.