Alcami Carolinas Corporation
FDA inspection history in Charleston, South Carolina, 2017 to 2024
- 3
- Form 483s
Every document, by year
- Form 483
2017: one Form 483; 2021: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017One Form 483, at Charleston, South Carolina.
- 2021One Form 483, at Charleston, South Carolina.
- 2021The longest 483 on file: 4 observations over 4 pages at Charleston, South Carolina.
- 2024One Form 483, at Charleston, South Carolina.
Cited most
Across all Alcami Carolinas observations on file
- 21 CFR 211.160General requirements3
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.165Testing and release for distribution1
- 21 CFR 211.192Production record review1
- 21 CFR 211.22Responsibilities of quality control unit1
The complete Alcami Carolinas 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
Charleston, South Carolina
Three Form 483s · 2017 to 2024 · 7 observations
Latest: Form 483, Apr 5, 2024 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-04-05 | 483 Form 483 | Charleston, South Carolina | 1 | $99 |
| 2021-10-29 | 483 Form 483 | Charleston, South Carolina | 4 | $99 |
| 2017-12-15 | 483 Form 483 | Charleston, South Carolina | 2 | $99 |
Investigators on these documents
Larry K. Hampton (1)Rodney L. Tinzie (1)Santos E. Camara (1)Zhao Wang (1)
FEI number 1000110990 · most recent document Apr 5, 2024
About Alcami Carolinas Corporation
How many FDA Form 483s has Alcami Carolinas Corporation received?
FDA Intel has 3 Form 483s on file for Alcami Carolinas Corporation; the most recent is dated Apr 5, 2024.
When was Alcami Carolinas Corporation last inspected by FDA?
The most recent FDA inspection document on file for Alcami Carolinas Corporation is a Form 483 dated Apr 5, 2024, for the site in Charleston, South Carolina.
What did FDA cite at Alcami Carolinas Corporation?
The regulations cited most in the observations on file for Alcami Carolinas Corporation are 21 CFR 211.160 (General requirements), 3 times; 21 CFR 211.113 (Control of microbiological contamination), 1 time; 21 CFR 211.165 (Testing and release for distribution), 1 time.