Ambiopharm, Inc.
Form 483 issued February 9, 2023 · North Augusta, South Carolina
- Inspection
- Feb 1 – Feb 9, 2023
- Investigator
- Libia M. Lugo
- Observations
- 2
- Pages
- 5
- FEI number
- 3006446551
In short: On February 9, 2023, FDA issued a Form 483 with 2 observations to Ambiopharm, Inc. in North Augusta, South Carolina (FEI 3006446551) after an inspection that ran Feb 1 – Feb 9, 2023. The investigator was Libia M. Lugo. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Quality system and production account for 2 of 2 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
PAI: Investigations conducted by your QC laboratory on out-of-specification results repeatedly determined that the results obtained…
- 02
Your firm failed to have sufficient controls over (b)(4) systems to ensure that microbiological criteria are…
This inspection in context
Libia M. Lugo
24 documents · 2013–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmAmbiopharm, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Ambiopharm, Inc.?
FDA listed 2 observations on this Form 483, mostly about quality system and production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Ambiopharm, Inc.?
Libia M. Lugo is named on this Form 483, for the inspection of Feb 1 – Feb 9, 2023. Each investigator has a profile showing what they cite most.
When was Ambiopharm, Inc. inspected by FDA?
The inspection ran Feb 1 – Feb 9, 2023, and the Form 483 is dated February 9, 2023.
How do I get the full Form 483 for Ambiopharm, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.