Skyless LLC
FDA inspection history in Ponce, Puerto Rico, 2022 to 2023
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2022: one Form 483; 2023: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2022–23One Form 483 and one warning letter, at Ponce, Puerto Rico.
Cited most
Across all Skyless observations on file
- 21 CFR 211.100(a)Written procedures; deviations1
- 21 CFR 211.22(d)Responsibilities of quality control unit1
- 21 CFR 211.25(a)Personnel qualifications1
- 21 CFR 211.67(b)Equipment cleaning and maintenance1
- 21 CFR 211.84(d)(2)Testing and approval or rejection of components, drug product containers, and closures1
The complete Skyless file.
All 2 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
Ponce, Puerto Rico
One warning letter and one Form 483 · 2022 to 2023 · 5 observations
Latest: Warning letter, Jan 23, 2023 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-01-23 | Warning letter Warning letter | Ponce, Puerto Rico | — | $99 |
| 2022-05-16 | 483 Form 483 | Ponce, Puerto Rico | 5 | $99 |
Investigators on these documents
FEI number 3020256087 · most recent document Jan 23, 2023
About Skyless LLC
How many FDA Form 483s has Skyless LLC received?
FDA Intel has 1 Form 483 on file for Skyless LLC; the most recent is dated May 16, 2022.
When was Skyless LLC last inspected by FDA?
The most recent FDA inspection document on file for Skyless LLC is a Form 483 dated May 16, 2022, for the site in Ponce, Puerto Rico.
What did FDA cite at Skyless LLC?
The regulations cited most in the observations on file for Skyless LLC are 21 CFR 211.100(a) (Written procedures; deviations), 1 time; 21 CFR 211.22(d) (Responsibilities of quality control unit), 1 time; 21 CFR 211.25(a) (Personnel qualifications), 1 time.
Has Skyless LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Skyless LLC; the most recent is dated Jan 23, 2023.