Aquascience Technologies & Research, Inc.
Form 483 issued February 19, 2019 · Richmond, Missouri
- Inspection
- Feb 11 – Feb 19, 2019
- Investigators
- Rita K. Kabaso· Wayne D. McGrath
- Observations
- 7
- Pages
- 6
- FEI number
- 1000050252
In short: On February 19, 2019, FDA issued a Form 483 with 7 observations to Aquascience Technologies & Research, Inc. in Richmond, Missouri (FEI 1000050252) after an inspection that ran Feb 11 – Feb 19, 2019. The investigators were Rita K. Kabaso and Wayne D. McGrath. Most observations concern quality system and packaging & labeling; the most-cited regulation is 21 CFR 211.122 (materials examination and usage criteria).
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observation- 01
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 02
Written records are not made of investigations into unexplained discrepancies and the failure of a batch…
- 03
Written production and process control procedures are not documented at…
- 04
The number of contamers to be sampled and amount of material taken from each container is…
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 firmAquascience Technologies & Research, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.165(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Aquascience Technologies & Research, Inc.?
FDA listed 7 observations on this Form 483, mostly about quality system, packaging & labeling and laboratory controls. The most-cited regulation is 21 CFR 211.122 (materials examination and usage criteria). The opening words of each observation are shown on this page.
Who inspected Aquascience Technologies & Research, Inc.?
Rita K. Kabaso and Wayne D. McGrath are named on this Form 483, for the inspection of Feb 11 – Feb 19, 2019. Each investigator has a profile showing what they cite most.
When was Aquascience Technologies & Research, Inc. inspected by FDA?
The inspection ran Feb 11 – Feb 19, 2019, and the Form 483 is dated February 19, 2019.
How do I get the full Form 483 for Aquascience Technologies & Research, 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.