GADAL Laboratories, Inc.
FDA inspection history in Miami, Florida, 2016 to 2023
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Warning letter
- Form 483
2016: one Form 483; 2023: one warning letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016One Form 483, at Miami, Florida.
- 2023One warning letter and one Form 483, at Miami, Florida.
- 2023The longest 483 on file: 12 observations over 11 pages at Miami, Florida.
Cited most
Across all GADAL Laboratories observations on file
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.160General requirements2
- 21 CFR 211.192Production record review2
- 21 CFR 211.194Laboratory records2
- 21 CFR 211.68Automatic, mechanical, and electronic equipment2
The complete GADAL Laboratories file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Miami, Florida
Two Form 483s and one warning letter · 2016 to 2023 · 17 observations
Latest: Warning letter, Aug 15, 2023 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-08-15 | Warning letter Warning letter | Miami, Florida | — | $99 |
| 2023-02-17 | 483 Form 483 | Miami, Florida | 12 | $99 |
| 2016-04-28 | 483 Form 483 | Miami, Florida | 5 | $99 |
Investigators on these documents
FEI number 3008611487 · most recent document Aug 15, 2023
About GADAL Laboratories, Inc.
How many FDA Form 483s has GADAL Laboratories, Inc. received?
FDA Intel has 2 Form 483s on file for GADAL Laboratories, Inc.; the most recent is dated Feb 17, 2023.
When was GADAL Laboratories, Inc. last inspected by FDA?
The most recent FDA inspection document on file for GADAL Laboratories, Inc. is a Form 483 dated Feb 17, 2023, for the site in Miami, Florida.
What did FDA cite at GADAL Laboratories, Inc.?
The regulations cited most in the observations on file for GADAL Laboratories, Inc. are 21 CFR 211.100 (Written procedures; deviations), 2 times; 21 CFR 211.160 (General requirements), 2 times; 21 CFR 211.192 (Production record review), 2 times.
Has GADAL Laboratories, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for GADAL Laboratories, Inc.; the most recent is dated Aug 15, 2023.