ABC Compounding Co., Inc.
Form 483 issued April 21, 2023 · Conyers, Georgia
- Investigator
- Marvin D. Jones
- Observations
- 12
- Pages
- 7
- FEI number
- 3012553246
In short: On April 21, 2023, FDA issued a Form 483 with 12 observations to ABC Compounding Co., Inc. in Conyers, Georgia (FEI 3012553246). The investigator was Marvin D. Jones. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Observations span 4 systems, led by laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
Drug products failing to meet established specifications and quality control…
- 02
Reprocessing procedures lack the steps to be taken to insure that reprocessed batches will conform with…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans…
- 04
Establishment of the reliability of the component supplier's report of analyses is deficient in that the…
This inspection in context
Marvin D. Jones
22 documents · 2007–2025
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Mississippi.
The firmABC Compounding Co., Inc. history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.165(f)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at ABC Compounding Co., Inc.?
FDA listed 12 observations on this Form 483, mostly about laboratory controls, production and quality system. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected ABC Compounding Co., Inc.?
Marvin D. Jones is named on this Form 483. Each investigator has a profile showing what they cite most.
When was ABC Compounding Co., Inc. inspected by FDA?
This Form 483 is dated April 21, 2023.
How do I get the full Form 483 for ABC Compounding Co., 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.