Westlab Pharmacy Inc.
FDA inspection history in Gainesville, Florida, 2018 to 2021
- 2
- Form 483s
- 1
- Close-out
Every document, by year
- Form 483
- Close-out
2018: one Form 483; 2019: one close-out letter; 2021: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2018–21Two Form 483s and one close-out letter, at Gainesville, Florida.
- 2018The longest 483 on file: 9 observations over 5 pages at Gainesville, Florida.
Cited most
Across all Westlab Pharmacy observations on file
- FDCA 501(a)(2)(A)Insanitary conditions5
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.56Sanitation3
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures2
The complete Westlab Pharmacy 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
Gainesville, Florida
Two Form 483s and one close-out letter · 2018 to 2021 · 17 observations
Latest: Form 483, Oct 5, 2021 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2021-10-05 | 483 Form 483 | Gainesville, Florida | 8 | $99 |
| 2019-06-26 | Close-out Close-out letter | Gainesville, Florida | — | $99 |
| 2018-08-15 | 483 Form 483 | Gainesville, Florida | 9 | $99 |
Investigators on these documents
FEI number 3007426960 · most recent document Oct 5, 2021
About Westlab Pharmacy Inc.
How many FDA Form 483s has Westlab Pharmacy Inc. received?
FDA Intel has 2 Form 483s on file for Westlab Pharmacy Inc.; the most recent is dated Oct 5, 2021.
When was Westlab Pharmacy Inc. last inspected by FDA?
The most recent FDA inspection document on file for Westlab Pharmacy Inc. is a Form 483 dated Oct 5, 2021, for the site in Gainesville, Florida.
What did FDA cite at Westlab Pharmacy Inc.?
The regulations cited most in the observations on file for Westlab Pharmacy Inc. are FDCA 501(a)(2)(A) (Insanitary conditions), 5 times; 21 CFR 211.113 (Control of microbiological contamination), 3 times; 21 CFR 211.56 (Sanitation), 3 times.