Balassa Laboratories Inc.
Form 483 issued April 7, 2023 · Port Orange, Florida
- Inspection
- Apr 3 – Apr 7, 2023
- Investigator
- Harshal J. Desai
- Observations
- 3
- Pages
- 3
- FEI number
- 1050280
In short: On April 7, 2023, FDA issued a Form 483 with 3 observations to Balassa Laboratories Inc. in Port Orange, Florida (FEI 1050280) after an inspection that ran Apr 3 – Apr 7, 2023. The investigator was Harshal J. Desai. Most observations concern production and materials.
At a glance
2 of 3 observations on this 483 concern production.
What FDA observed
Preview: the opening words of each observation- 01
There was a failure to handle and store components at all times in a…
- 02
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 03
All major equipment used during the production of a batch of drug product is not properly…
This inspection in context
Harshal J. Desai
6 documents · 2022–2024
Cites 211.100(a) (written procedures; deviations) more than any other section. Most of their documents are for sites in Florida.
The firmBalassa Laboratories Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.80(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Balassa Laboratories Inc.?
FDA listed 3 observations on this Form 483, mostly about production and materials. The opening words of each observation are shown on this page.
Who inspected Balassa Laboratories Inc.?
Harshal J. Desai is named on this Form 483, for the inspection of Apr 3 – Apr 7, 2023. Each investigator has a profile showing what they cite most.
When was Balassa Laboratories Inc. inspected by FDA?
The inspection ran Apr 3 – Apr 7, 2023, and the Form 483 is dated April 7, 2023.
How do I get the full Form 483 for Balassa Laboratories 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.