Balassa Laboratories Inc.
FDA inspection history in Port Orange, Florida, 2023
- 1
- Form 483
Every document, by year
- Form 483
2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2023One Form 483, at Port Orange, Florida.
Cited most
Across all Balassa Laboratories observations on file
- 21 CFR 211.105(a)Equipment identification1
- 21 CFR 211.110(a)Sampling and testing of in-process materials and drug products1
- 21 CFR 211.80(b)General requirements1
The complete Balassa Laboratories file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Port Orange, Florida
One Form 483 · 2023 · 3 observations
Latest: Form 483, Apr 7, 2023 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-04-07 | 483 Form 483 | Port Orange, Florida | 3 | $99 |
Investigators on these documents
FEI number 1050280 · most recent document Apr 7, 2023
About Balassa Laboratories Inc.
How many FDA Form 483s has Balassa Laboratories Inc. received?
FDA Intel has 1 Form 483 on file for Balassa Laboratories Inc.; the most recent is dated Apr 7, 2023.
When was Balassa Laboratories Inc. last inspected by FDA?
The most recent FDA inspection document on file for Balassa Laboratories Inc. is a Form 483 dated Apr 7, 2023, for the site in Port Orange, Florida.
What did FDA cite at Balassa Laboratories Inc.?
The regulations cited most in the observations on file for Balassa Laboratories Inc. are 21 CFR 211.105(a) (Equipment identification), 1 time; 21 CFR 211.110(a) (Sampling and testing of in-process materials and drug products), 1 time; 21 CFR 211.80(b) (General requirements), 1 time.