Baxalta US Inc.

FDA inspection history in Social Circle, Georgia, 2021

1
Form 483

Every document, by year

  • Form 483

2021: one Form 483.

The story so far

Built from the dates and citations on the documents themselves.

  1. 2021One Form 483, at Social Circle, Georgia.

Cited most

Across all Baxalta US observations on file

The complete Baxalta US file.

All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.

$99

The documents one by one, while the file is prepared

See the documents

Sites

Documents

1 on file, newest first
DateDocumentPrice
2021-07-01483 Form 483$99

FEI number 3013980449 · most recent document Jul 1, 2021

About Baxalta US Inc.

How many FDA Form 483s has Baxalta US Inc. received?

FDA Intel has 1 Form 483 on file for Baxalta US Inc.; the most recent is dated Jul 1, 2021.

When was Baxalta US Inc. last inspected by FDA?

The most recent FDA inspection document on file for Baxalta US Inc. is a Form 483 dated Jul 1, 2021, for the site in Social Circle, Georgia.

What did FDA cite at Baxalta US Inc.?

The regulations cited most in the observations on file for Baxalta US Inc. are 21 CFR 211.113 (Control of microbiological contamination), 1 time; 21 CFR 211.194 (Laboratory records), 1 time; 21 CFR 600.14 (Reporting of biological product deviations by licensed manufacturers), 1 time.