Genlabs Corporation
Form 483 issued December 11, 2015 · Chino, California
- Inspection
- Dec 7 – Dec 11, 2015
- Investigators
- Djamila Harouaka· Marcus F. Yambot
- Observations
- 10
- Pages
- 6
- FEI number
- 1000125638
In short: On December 11, 2015, FDA issued a Form 483 with 10 observations to Genlabs Corporation in Chino, California (FEI 1000125638) after an inspection that ran Dec 7 – Dec 11, 2015. The investigators were Djamila Harouaka and Marcus F. Yambot. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and quality system account for 6 of 10 observations.
What FDA observed
Preview: the opening words of each observation- 01
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would…
- 02
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils…
- 03
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 04
Drug product component testing is deficient in that at least one specific test to verify the…
This inspection in context
Djamila Harouaka
15 documents · 2015–2023
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmGenlabs Corporation history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Genlabs Corporation?
FDA listed 10 observations on this Form 483, mostly about facilities & equipment, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Genlabs Corporation?
Djamila Harouaka and Marcus F. Yambot are named on this Form 483, for the inspection of Dec 7 – Dec 11, 2015. Each investigator has a profile showing what they cite most.
When was Genlabs Corporation inspected by FDA?
The inspection ran Dec 7 – Dec 11, 2015, and the Form 483 is dated December 11, 2015.
How do I get the full Form 483 for Genlabs Corporation?
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.