Maitland Labs of Central Florida
FDA inspection history in Orlando, Florida, 2019 to 2021
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Warning letter
- Form 483
2019: one Form 483; 2020: one Form 483; 2021: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2019–21Two Form 483s and one warning letter, at Orlando, Florida.
- 2019The longest 483 on file: 9 observations over 5 pages at Orlando, Florida.
Cited most
Across all Maitland Labs of Central Florida observations on file
- 21 CFR 211.42(c)(10)(iii)Design and construction features4
- FDCA 503B(a)(10)4
- 21 CFR 211.166(a)Stability testing2
- 21 CFR 211.167(a)Special testing requirements2
- 21 CFR 211.113(b)Control of microbiological contamination1
The complete Maitland Labs of Central Florida 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
Orlando, Florida
Two Form 483s and one warning letter · 2019 to 2021 · 16 observations
Latest: Warning letter, Aug 6, 2021 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2021-08-06 | Warning letter Warning letter | Orlando, Florida | — | $99 |
| 2020-02-28 | 483 Form 483 | Orlando, Florida | 7 | $99 |
| 2019-06-17 | 483 Form 483 | Orlando, Florida | 9 | $99 |
Investigators on these documents
FEI number 3013854204 · most recent document Aug 6, 2021
About Maitland Labs of Central Florida
How many FDA Form 483s has Maitland Labs of Central Florida received?
FDA Intel has 2 Form 483s on file for Maitland Labs of Central Florida; the most recent is dated Feb 28, 2020.
When was Maitland Labs of Central Florida last inspected by FDA?
The most recent FDA inspection document on file for Maitland Labs of Central Florida is a Form 483 dated Feb 28, 2020, for the site in Orlando, Florida.
What did FDA cite at Maitland Labs of Central Florida?
The regulations cited most in the observations on file for Maitland Labs of Central Florida are 21 CFR 211.42(c)(10)(iii) (Design and construction features), 4 times; FDCA 503B(a)(10), 4 times; 21 CFR 211.166(a) (Stability testing), 2 times.
Has Maitland Labs of Central Florida received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Maitland Labs of Central Florida; the most recent is dated Aug 6, 2021.