Ambiopharm, Inc.

FDA inspection history in North Augusta, South Carolina, 2023

1
Form 483

Every document, by year

  • Form 483

2023: one Form 483.

The story so far

Built from the dates and citations on the documents themselves.

  1. 2023One Form 483, at North Augusta, South Carolina.

Cited most

Across all Ambiopharm observations on file

The complete Ambiopharm 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
2023-02-09483 Form 483$99

Investigators on these documents

Libia M. Lugo (1)

FEI number 3006446551 · most recent document Feb 9, 2023

About Ambiopharm, Inc.

How many FDA Form 483s has Ambiopharm, Inc. received?

FDA Intel has 1 Form 483 on file for Ambiopharm, Inc.; the most recent is dated Feb 9, 2023.

When was Ambiopharm, Inc. last inspected by FDA?

The most recent FDA inspection document on file for Ambiopharm, Inc. is a Form 483 dated Feb 9, 2023, for the site in North Augusta, South Carolina.

What did FDA cite at Ambiopharm, Inc.?

The regulations cited most in the observations on file for Ambiopharm, Inc. are 21 CFR 211.113 (Control of microbiological contamination), 1 time; 21 CFR 211.160 (General requirements), 1 time; 21 CFR 211.192 (Production record review), 1 time.