American Laboratories Pharma, LLC
FDA inspection history in Omaha, Nebraska, 2017 to 2024
- 3
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2017: one Form 483; 2022: one Form 483; 2023: one warning letter; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017One Form 483, at Omaha, Nebraska.
- 2022–24Two Form 483s and one warning letter, at Omaha, Nebraska.
- 2022The longest 483 on file: 4 observations over 7 pages at Omaha, Nebraska.
Cited most
Across all American Laboratories Pharma observations on file
- 21 CFR 211.192Production record review4
- 21 CFR 211.110Sampling and testing of in-process materials and drug products2
- 21 CFR 211.160General requirements1
- 21 CFR 211.166Stability testing1
- 21 CFR 211.198Complaint files1
The complete American Laboratories Pharma file.
All 4 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
Omaha, Nebraska
Three Form 483s and one warning letter · 2017 to 2024 · 10 observations
Latest: Form 483, May 3, 2024 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-05-03 | 483 Form 483 | Omaha, Nebraska | 2 | $99 |
| 2023-03-30 | Warning letter Warning letter | Omaha, Nebraska | — | $99 |
| 2022-10-03 | 483 Form 483 | Omaha, Nebraska | 4 | $99 |
| 2017-12-01 | 483 Form 483 | Omaha, Nebraska | 4 | $99 |
Investigators on these documents
FEI number 1920841 · most recent document May 3, 2024
About American Laboratories Pharma, LLC
How many FDA Form 483s has American Laboratories Pharma, LLC received?
FDA Intel has 3 Form 483s on file for American Laboratories Pharma, LLC; the most recent is dated May 3, 2024.
When was American Laboratories Pharma, LLC last inspected by FDA?
The most recent FDA inspection document on file for American Laboratories Pharma, LLC is a Form 483 dated May 3, 2024, for the site in Omaha, Nebraska.
What did FDA cite at American Laboratories Pharma, LLC?
The regulations cited most in the observations on file for American Laboratories Pharma, LLC are 21 CFR 211.192 (Production record review), 4 times; 21 CFR 211.110 (Sampling and testing of in-process materials and drug products), 2 times; 21 CFR 211.160 (General requirements), 1 time.
Has American Laboratories Pharma, LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for American Laboratories Pharma, LLC; the most recent is dated Mar 30, 2023.