Sky Systems Co., Inc
Form 483 issued September 30, 2020 · Ontario, California
- Inspection
- Sep 21 – Sep 30, 2020
- Investigator
- Lisa Shin
- Observations
- 12
- Pages
- 10
- FEI number
- 1000331562
In short: On September 30, 2020, FDA issued a Form 483 with 12 observations to Sky Systems Co., Inc in Ontario, California (FEI 1000331562) after an inspection that ran Sep 21 – Sep 30, 2020. The investigator was Lisa Shin. Most observations concern quality system and laboratory controls.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observation- 01
There is no quality…
- 02
Records are not maintained so that data therein can be reviewed at least annually to evaluate…
- 03
Batch production and control records are not prepared for each batch of drug product produced and…
- 04
Written records are not made of investigations into unexplained discrepancies and the failure of a batch…
This inspection in context
Lisa Shin
13 documents · 2020–2023
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.
The firmSky Systems Co., Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sky Systems Co., Inc?
FDA listed 12 observations on this Form 483, mostly about quality system, laboratory controls and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Sky Systems Co., Inc?
Lisa Shin is named on this Form 483, for the inspection of Sep 21 – Sep 30, 2020. Each investigator has a profile showing what they cite most.
When was Sky Systems Co., Inc inspected by FDA?
The inspection ran Sep 21 – Sep 30, 2020, and the Form 483 is dated September 30, 2020.
How do I get the full Form 483 for Sky Systems Co., 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.