ABC Compounding Co., Inc.
FDA inspection history across 2 sites, 2004 to 2023
- 2
- Close-outs
- 1
- Form 483
- 1
- Warning letter
Every document, by year
- Form 483
- Close-out
- Warning letter
2004: one warning letter; 2019: two close-out letters; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2004One warning letter, at Morrow, Georgia.
- 2019Two close-out letters, at Conyers, Georgia and Morrow, Georgia.
- 2023One Form 483, at Conyers, Georgia.
Cited most
Across all ABC Compounding Co. observations on file
- 21 CFR 211.160(b)General requirements2
- 21 CFR 211.110(a)Sampling and testing of in-process materials and drug products1
- 21 CFR 211.111Time limitations on production1
- 21 CFR 211.115(a)Reprocessing1
- 21 CFR 211.137(a)Expiration dating1
The complete ABC Compounding Co. 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
Conyers, Georgia
One Form 483 and one close-out letter · 2019 to 2023 · 12 observations
Latest: Form 483, Apr 21, 2023 →Morrow, Georgia
One close-out letter and one warning letter · 2004 to 2019
Latest: Close-out, Apr 18, 2019 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-04-21 | 483 Form 483 | Conyers, Georgia | 12 | $99 |
| 2019-05-02 | Close-out Close-out letter | Conyers, Georgia | — | $99 |
| 2019-04-18 | Close-out Close-out letter | Morrow, Georgia | — | $99 |
| 2004-11-01 | Warning letter Warning letter | Morrow, Georgia | — | $99 |
Investigators on these documents
FEI number 3012553246 · most recent document Apr 21, 2023
About ABC Compounding Co., Inc.
How many FDA Form 483s has ABC Compounding Co., Inc. received?
FDA Intel has 1 Form 483 on file for ABC Compounding Co., Inc.; the most recent is dated Apr 21, 2023.
When was ABC Compounding Co., Inc. last inspected by FDA?
The most recent FDA inspection document on file for ABC Compounding Co., Inc. is a Form 483 dated Apr 21, 2023, for the site in Conyers, Georgia.
What did FDA cite at ABC Compounding Co., Inc.?
The regulations cited most in the observations on file for ABC Compounding Co., Inc. are 21 CFR 211.160(b) (General requirements), 2 times; 21 CFR 211.110(a) (Sampling and testing of in-process materials and drug products), 1 time; 21 CFR 211.111 (Time limitations on production), 1 time.
Has ABC Compounding Co., Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for ABC Compounding Co., Inc.; the most recent is dated Nov 1, 2004.