Central Solutions Inc.
Form 483 issued November 21, 2019 · Kansas City, Kansas
- Inspection
- Nov 13 – Nov 21, 2019
- Investigator
- Rita K. Kabaso
- Observations
- 9
- Pages
- 8
- FEI number
- 1000138339
In short: On November 21, 2019, FDA issued a Form 483 with 9 observations to Central Solutions Inc. in Kansas City, Kansas (FEI 1000138339) after an inspection that ran Nov 13 – Nov 21, 2019. The investigator was Rita K. Kabaso. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and laboratory controls account for 6 of 9 observations.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
Deviations from written specifications…
- 03
There are no written procedures for production and process controls designed to assure that the drug…
- 04
Written records are not made of investigations into unexplained discrepancies and the failure of a batch…
This inspection in context
Rita K. Kabaso
18 documents · 2015–2023
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmCentral Solutions Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Central Solutions Inc.?
FDA listed 9 observations on this Form 483, mostly about quality system, laboratory controls and production. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Central Solutions Inc.?
Rita K. Kabaso is named on this Form 483, for the inspection of Nov 13 – Nov 21, 2019. Each investigator has a profile showing what they cite most.
When was Central Solutions Inc. inspected by FDA?
The inspection ran Nov 13 – Nov 21, 2019, and the Form 483 is dated November 21, 2019.
How do I get the full Form 483 for Central Solutions 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.