Ampak Chemicals Incorporated
Form 483 issued April 9, 2021 · Carson, California
- Inspection
- Mar 24 – Apr 9, 2021
- Investigators
- Heidy C. Perales· Stephanie A. Slater
- Observations
- 6
- Pages
- 7
- FEI number
- 3006434073
In short: On April 9, 2021, FDA issued a Form 483 with 6 observations to Ampak Chemicals Incorporated in Carson, California (FEI 3006434073) after an inspection that ran Mar 24 – Apr 9, 2021. The investigators were Heidy C. Perales and Stephanie A. Slater. Most observations concern laboratory controls and quality system; 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
There is no quality…
- 02
Written procedures are lacking which describe in sufficient detail the receipt, identification, storage, handling, sampling, testing…
- 03
There are no written procedures for production and process controls designed to assure that the drug…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans…
This inspection in context
Heidy C. Perales
5 documents · 2021–2023
Cites 211.160(b) (general requirements) more than any other section. Most of their documents are for sites in California.
The firmAmpak Chemicals Incorporated history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Ampak Chemicals Incorporated?
FDA listed 6 observations on this Form 483, mostly about laboratory controls, quality system and materials. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Ampak Chemicals Incorporated?
Heidy C. Perales and Stephanie A. Slater are named on this Form 483, for the inspection of Mar 24 – Apr 9, 2021. Each investigator has a profile showing what they cite most.
When was Ampak Chemicals Incorporated inspected by FDA?
The inspection ran Mar 24 – Apr 9, 2021, and the Form 483 is dated April 9, 2021.
How do I get the full Form 483 for Ampak Chemicals Incorporated?
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.